AzTrials
AzTrials

Memory DeficitsPhase 2CleverAgeBiotaNCT05051501

The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population

A Phase 2 study testing Probiotics C2P in people with Memory Deficits and Mood Change, run by National Institute of Mental Health, Czech Republic at 2 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this project is to develop probiotic dietary supplements intended for the elderly, which can modify the composition of the intestinal microbiota typically occurring in the aging population. Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Memory Deficits, Mood Change, Gut Health
What is being tested?
Probiotics C2P
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesCzechia
Study dates
6 Jan 2021to 2 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • is 55-80 years of age
  • His/her native language is Czech
  • Is willing to visit the testing centre four times within half a year
  • Is willing to provide blood, urine and stool samples three times within half a year
  • Is willing to self-administer the probiotic/placebo pill once every day for half a year
  • is self-sufficient (handling finances, travelling without a chaperone, administration of medication, correct phone usage, filling forms, meal preparation)
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  • Has good vision; Can read and write, glasses are acceptable
  • Has good hearing to hear and understand all instructions during examination
  • Can walk well (walking aids are acceptable) to attend all the examinations

Who cannot join

  • Suffers with disorder(s) of digestive system, primarily gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease, frequent diarrhoea)
  • Had severe neurological difficulties (epilepsy, stroke, severe head trauma, meningitis in the past 10 years, brain surgery, brain tumour, prolonged period(s) in an unconscious state - excluding general anaesthesia)
  • Had been treated/Is currently being treated for the following psychiatric disorders: alcohol/medication/drug of abuse dependance, schizophrenia, psychotic disorder, bipolar disorder
  • Is taking medication for depression or low mood
  • Suffers from internal organ failure (heart, liver or kidney failure etc.)
  • Suffered from an oncological problem (cancer) in the past 5 years
Show all 10Show fewer
  • Underwent radiotherapy or chemotherapy in the past
  • Underwent a surgery/procedure under general anaesthesia in the past three years or has a planned procedure/surgery under general anaesthesia in the next 6 months over the course of this trial
  • Suffered from hepatitis (hepatitis B, C), HIV or syphilis in the past
  • Had taken any probiotics in the past three months

Trial locations and contacts

2 sites in 1 country.

Czechia2 sites

  • University Hospital Vinohrady

    Prague, 10034

  • National Institute of Mental Health, Czech Republic

    Prague, 25067

Other trials in Czechia

About this study

Official title: Biotechnology Research Into Microbiological Spectrum Changes to Improve Cognitive Functions, Depression and Other Neuropsychiatric Disorders in Aging Population

The goal of this project is to develop probiotic dietary supplements intended for the elderly, which can modify the composition of the intestinal microbiota typically occurring in the aging population. According to currently held scientific knowledge, it is postulated that the probiotics-induced normalization of the physiological axis in the brain-intestinal microbiota affects the activity of the nervous system. Thus, normalization of this axis should lead to observable improvements in cognitive functions and quality of life.

Read the detailed description

With an increasing age of the population, the incidence of age-related problems, such as memory deficits or negative changes in mood, is on the rise. On this account, an increased emphasis has been placed on identifying natural ways to reduce the occurrence of such problems. One of the proposed methods to achieve this is to modify the composition of gut bacteria and their by-products, which has shown a surprising, yet highly promising potential to benefit the brain function and blood composition.

In the recent years, gut bacteria have been of great interest to many medical professionals from various disciplines. It is postulated that they might exert some influence on memory and emotions, but there is a lack of evidence to confirm these hypotheses. Our study would like to address this issue and examine the beneficial effects of probiotics into more depth. Probiotics are dietary supplements in the form of bacteria, which are often artificially added e.g. into some dairy products. This is done to promote gut health and to improve the quality of gut microflora.

The subject selection and assessment are summarised as follows: Participants will be pre-selected electronically and given an electronic memory test. Further selection of eligible subjects based on their preliminary results will be followed by the first personal appointment, where each participant will undergo memory and mood-focused psychological testing and testing for gut bacteria composition. One week after the initial appointment, participants will be asked to bring in a stool and urine sample, their blood will be collected and their fitness and dietary habits assessed. Each participant will also be given an electronic watch, which will monitor their physical activity, and supplements in the pill form, which either contain specially cultivated human gut bacteria (i.e. probiotics) or placebo. Identical tests and blood, urine and stool collection will be repeated three months after administering the first pill. The participants will receive another set of pills, which will contain the probiotics if the participant has initially received placebo and vice versa. After three more months, participants will be subjected to the same tests as in the previous two instants. To test for lasting effects of treatment, participants will be tested again after 3 more months and the project will reach its termination.

Using the above-mentioned methods, the aim of this project is to provide sufficient evidence of the beneficial effects of the new probiotics on memory, mood and the biochemical components contained in the blood, stool and urine in elderly population.

Being tested
Probiotics C2P
Keywords
Probiotics, Microbiome, Gut Microflora, Cognitive Health
Medical subject headings
Memory Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotics C2PDietary supplement

    Probiotics will supplement normal diet. Unlike other products available on the market, which are usually of bovine origin, our probiotic has been manufactured using human-stemmed lines. The supplements are composed of a mixture of naturally occurring human gut bacteria.

Study groups in NCT05051501
Study groupRoleWhat they receive
Probiotics C2P/PlaceboExperimentalCrossover design does not confine one group of patients strictly either to an intervention in question or a placebo. Each group will receive both placebo and probiotics in tandem, but in a reversed order.
Receives: Dietary Supplement: Probiotics C2P
Placebo/Probiotics C2PExperimentalCrossover design does not confine one group of patients strictly either to an intervention in question or a placebo. Each group will receive both placebo and probiotics in tandem, but in a reversed order.
Receives: Dietary Supplement: Probiotics C2P

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

    Measured: baseline to 3 months

  2. Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

    Measured: baseline to 6 months

  3. Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

    Measured: 3 months to 6 months

  4. Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

    Measured: 6 months to 9 months

  5. Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

    Measured: 3 months

  6. Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

    Measured: 6 months

  7. Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

    Measured: baseline to 3 months

  8. Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

    Measured: baseline to 6 months

  9. Change from 3 months cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

    Measured: 3 months to 6 months

  10. Change from 6 months cognitive function in the Assessment Battery of Cognition (ABACO) at 9 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

    Measured: 6 months to 9 months

  11. Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

    Measured: 3 months

  12. Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

    Measured: 6 months

  13. Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

    Measured: baseline to 3 months

  14. Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

    Measured: baseline to 6 months

  15. Change from 3 months cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

    Measured: 3 months to 6 months

  16. Change from 6 months cognitive function in Semantic word recollection (category: animals, 1 min) at 9 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

    Measured: 6 months to 9 months

  17. Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

    Measured: 3 months

  18. Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

    Measured: 6 months

  19. Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

    Measured: baseline to 3 months

  20. Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

    Measured: baseline to 6 months

  21. Change from 3 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

    Measured: 3 months to 6 months

  22. Change from 6 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 9 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

    Measured: 6 months to 9 months

  23. Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

    Measured: 3 months

  24. Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

    Measured: 6 months

  25. Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

    Measured: baseline to 3 months

  26. Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

    Measured: baseline to 6 months

  27. Change in 3 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

    Measured: 3 months to 6 months

  28. Change in 6 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 9 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

    Measured: 6 months to 9 months

  29. Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

    Measured: 3 months

  30. Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

    Measured: 6 months

  31. Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

    Measured: baseline to 3 months

  32. Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 6 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

    Measured: baseline to 6 months

  33. Change in 3 month cognitive function in Trail Making Test (TMT), Parts A & B at 6 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

    Measured: 3 months to 6 months

  34. Change in 6 month cognitive function in Trail Making Test (TMT), Parts A & B at 9 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

    Measured: 6 months to 9 months

  35. Difference cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    The TMT is a validated measure of cognitive function, the time upon completion is measured

    Measured: 3 months

  36. Difference cognitive function in Trail Making Test (TMT), Parts A & B at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    The TMT is a validated measure of cognitive function, the time upon completion is measured

    Measured: 6 months

  37. Change in baseline mood in Geriatric Depression Scale at 3 months.

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

    Measured: baseline to 3 months

  38. Change in baseline mood in Geriatric Depression Scale at 6 months.

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

    Measured: baseline to 6 months

  39. Change in 3 month mood in Geriatric Depression Scale at 6 months.

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

    Measured: 3 months to 6 months

  40. Change in 6 month mood in Geriatric Depression Scale at 9 months.

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

    Measured: 6 months to 9 months

  41. Difference in mood in Geriatric Depression Scale at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

    Measured: 3 months

  42. Difference in mood in Geriatric Depression Scale at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

    Measured: 6 months

  43. Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

    Measured: baseline to 3 months

  44. Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

    Measured: baseline to 6 months

  45. Change from 3 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

    Measured: 3 months to 6 months

  46. Change from 6 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 9 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

    Measured: 6 months to 9 months

  47. Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

    Measured: 3 months

  48. Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

    Measured: 6 months

  49. Changes in tau protein

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: baseline to 3 months

  50. Changes in tau protein

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: baseline to 6 months

  51. Changes in tau protein

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: 3 months to 6 months

  52. Changes in tau protein

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: 6 months to 9 months

  53. Changes in neurofilament light levels

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: baseline to 3 months

  54. Changes in neurofilament light levels

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: baseline to 6 months

  55. Changes in neurofilament light levels

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: 3 months to 6 months

  56. Changes in neurofilament light levels

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: 6 months to 9 months

  57. Changes in immunocomplex antibody levels

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: baseline to 3 months

  58. Changes in immunocomplex antibody levels

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: baseline to 6 months

  59. Changes in immunocomplex antibody levels

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: 3 months to 6 months

  60. Changes in immunocomplex antibody levels

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

    Measured: 6 months to 9 months

  61. Biochemical parameters in blood

    Change from baseline Blood metabolome assessed using mass spectrometry at 3 months

    Measured: baseline to 3 months

  62. Biochemical parameters in blood

    Change from baseline Blood metabolome assessed using mass spectrometry at 6 months

    Measured: baseline to 6 months

  63. Biochemical parameters in blood

    Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months

    Measured: 3 months to 6 months

  64. Biochemical parameters in blood

    Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months

    Measured: 6 months to 9 months

  65. Biochemical parameters in urine

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 3 months

    Measured: baseline to 3 months

  66. Biochemical parameters in urine

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 6 months

    Measured: baseline to 6 months

  67. Biochemical parameters in urine

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months

    Measured: 3 months to 6 months

  68. Biochemical parameters in urine

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months

    Measured: 6 months to 9 months

  69. Biochemical parameters in stool

    Change from baseline Stool metabolome assessed using mass spectrometry at 3 months

    Measured: baseline to 3 months

  70. Biochemical parameters in stool

    Change from baseline Stool metabolome assessed using mass spectrometry at 6 months

    Measured: baseline to 6 months

  71. Biochemical parameters in stool

    Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months

    Measured: 3 months to 6 months

  72. Biochemical parameters in stool

    Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months

    Measured: 6 months to 9 months

Secondary outcomes (84)

  1. Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

    Measured: baseline to 3 months

  2. Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

    Measured: baseline to 6 months

  3. Change from 3 months Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

    Measured: 3 months to 6 months

  4. Change from 6 months Questionnaire of adverse events (abbreviation in original language: DNU) at 9 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

    Measured: 6 months to 9 months

  5. Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

    Measured: 3 months

  6. Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

    Measured: 6 months

  7. Change from baseline Self-assessment of memory at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 3 months

  8. Change from baseline Self-assessment of memory at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 6 months

  9. Change from 3 months Self-assessment of memory at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months to 6 months

  10. Change from 6 months Self-assessment of memory at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months to 9 months

  11. Difference in Self-assessment of memory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months

  12. Difference in Self-assessment of memory at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months

  13. Change from baseline Self-assessment of digestion at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 3 months

  14. Change from baseline Self-assessment of digestion at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 6 months

  15. Change from 3 months Self-assessment of digestion at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months to 6 months

  16. Change from 6 months Self-assessment of digestion at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months to 9 months

  17. Difference in Self-assessment of digestion at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months

  18. Difference in Self-assessment of digestion at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months

  19. Change from baseline Self-assessment of overall health at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 3 months

  20. Change from baseline Self-assessment of overall health at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 6 months

  21. Change from 3 months Self-assessment of overall health at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months to 6 months

  22. Change from 6 months Self-assessment of overall health at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months to 9 months

  23. Difference in Self-assessment of overall health at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months

  24. Difference in Self-assessment of overall health at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months

  25. Change from baseline Self-assessment of sleep quality at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 3 months

  26. Change from baseline Self-assessment of sleep quality at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 6 months

  27. Change from 3 months Self-assessment of sleep quality at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months to 6 months

  28. Change from 6 months Self-assessment of sleep quality at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months to 9 months

  29. Difference in Self-assessment of sleep quality at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months

  30. Difference in Self-assessment of sleep quality at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months

  31. Change from baseline Self-assessment of anxiety at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: baseline to 3 months

  32. Change from baseline Self-assessment of anxiety at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: baseline to 6 months

  33. Change from 3 months Self-assessment of anxiety at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 3 months to 6 months

  34. Change from 6 months Self-assessment of anxiety at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 6 months to 9 months

  35. Difference in Self-assessment of anxiety at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 3 months

  36. Difference in Self-assessment of anxiety at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 6 months

  37. Change from baseline Self-assessment of fatigue at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: baseline to 3 months

  38. Change from baseline Self-assessment of fatigue at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: baseline to 6 months

  39. Change from 3 months Self-assessment of fatigue at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 3 months to 6 months

  40. Change from 6 months Self-assessment of fatigue at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 6 months to 9 months

  41. Difference in Self-assessment of fatigue at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 3 months

  42. Difference in Self-assessment of fatigue at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

    Measured: 6 months

  43. Change from baseline Self-assessment of pain at 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 3 months

  44. Change from baseline Self-assessment of pain at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: baseline to 6 months

  45. Change from 3 months Self-assessment of pain at 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months to 6 months

  46. Change from 6 months Self-assessment of pain at 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months to 9 months

  47. Difference in Self-assessment of pain at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 3 months

  48. Difference in Self-assessment of pain at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

    Measured: 6 months

  49. Change from baseline physical condition assessment in 30 second sit stand test at 3 months

    Number of sits and stands during 30 seconds

    Measured: baseline to 3 months

  50. Change from baseline physical condition assessment in 30 second sit stand test at 6 months

    Number of sits and stands during 30 seconds

    Measured: baseline to 6 months

  51. Change from 3 months physical condition assessment in 30 second sit stand test at 6 months

    Number of sits and stands during 30 seconds

    Measured: 3 months to 6 months

  52. Change from 6 months physical condition assessment in 30 second sit stand test at 9 months

    Number of sits and stands during 30 seconds

    Measured: 6 months to 9 months

  53. Difference in physical condition assessment in 30 second sit stand test at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Number of sits and stands during 30 seconds

    Measured: 3 months

  54. Difference in physical condition assessment in 30 second sit stand test at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Number of sits and stands during 30 seconds

    Measured: 6 months

  55. Change from baseline physical condition assessment in 30 second dumbell lift tests at 3 months

    Number lifts during 30 seconds

    Measured: baseline to 3 months

  56. Change from baseline physical condition assessment in 30 second dumbell lift tests at 6 months

    Number lifts during 30 seconds

    Measured: baseline to 6 months

  57. Change from 3 months physical condition assessment in 30 second dumbell lift tests at 6 months

    Number lifts during 30 seconds

    Measured: 3 months to 6 months

  58. Change from 6 months physical condition assessment in 30 second dumbell lift tests at 9 months

    Number lifts during 30 seconds

    Measured: 6 months to 9 months

  59. Difference in physical condition assessment in 30 second dumbell lift tests at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Number lifts during 30 seconds

    Measured: 3 months

  60. Difference in physical condition assessment in 30 second dumbell lift tests at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Number lifts during 30 seconds

    Measured: 6 months

  61. Change from baseline physical condition assessment in 30 meters walk at 3 months

    Time untill completion

    Measured: baseline to 3 months

  62. Change from baseline physical condition assessment in 30 meters walk at 6 months

    Time untill completion

    Measured: baseline to 6 months

  63. Change from 3 months physical condition assessment in 30 meters walk at 6 months

    Time untill completion

    Measured: 3 months to 6 months

  64. Change from 6 months physical condition assessment in 30 meters walk at 9 months

    Time untill completion

    Measured: 6 months to 9 months

  65. Difference in physical condition assessment in 30 meters walk at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time untill completion

    Measured: 3 months

  66. Difference in physical condition assessment in 30 meters walk at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time untill completion

    Measured: 6 months

  67. Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months

    Structured self-report questionnaire

    Measured: baseline to 3 months

  68. Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months

    Structured self-report questionnaire

    Measured: baseline to 6 months

  69. Change from 3 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months

    Structured self-report questionnaire

    Measured: 3 months to 6 months

  70. Change from 6 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 9 months

    Structured self-report questionnaire

    Measured: 6 months to 9 months

  71. Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Structured self-report questionnaire

    Measured: 3 months

  72. Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Structured self-report questionnaire

    Measured: 6 months

  73. Change in baseline Beck's Anxienty Inventory at 3 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

    Measured: baseline to 3 months

  74. Change in baseline Beck's Anxienty Inventory at 6 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

    Measured: baseline to 6 months

  75. Change in 3 months Beck's Anxienty Inventory at 6 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

    Measured: 3 months to 6 months

  76. Change in 6 months Beck's Anxienty Inventory at 9 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

    Measured: 6 months to 9 months

  77. Difference in Beck's Anxienty Inventory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

    Measured: 3 months

  78. Difference in Beck's Anxienty Inventory (BAI) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

    Measured: 6 months

  79. Change in baseline Beck's Depression Inventory - II (BDI-II) at 3 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

    Measured: baseline to 3 months

  80. Change in baseline Beck's Depression Inventory - II (BDI-II) at 6 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

    Measured: baseline to 6 months

  81. Change in 3 months Beck's Depression Inventory - II (BDI-II) at 6 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

    Measured: 3 months to 6 months

  82. Change in 6 months Beck's Depression Inventory - II (BDI-II) at 9 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

    Measured: 6 months to 9 months

  83. Difference in Beck's Depression Inventory - II (BDI-II) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

    Measured: 3 months

  84. Difference in Beck's Depression Inventory - II (BDI-II) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2021
  2. Study start6 Jan 2021
  3. Primary completion2 Mar 2022
  4. Study completion2 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
First 3 months: group A on probiotics; group B on placebo Next 3 months: group A on placebo; group B on probiotics. Next 3 months: no intervention in either group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05051501
Sponsor's protocol ID
FV-40032
Acronym
CleverAgeBiota
Status last verified
May 2023
First submitted
28 Apr 2021
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Bartos A, Weinerova J, Diondet S. Effects of human probiotics on memory and psychological and physical measures in community-dwelling older adults with normal and mildly impaired cognition: results of a bi-center, double-blind, randomized, and placebo-controlled clinical trial (CleverAge biota). Front Aging Neurosci. 2023 Jul 7;15:1163727. doi: 10.3389/fnagi.2023.1163727. eCollection 2023.

    PubMed 37502424

  • Bartos A, Weinerova J, Diondet S, Vales K. Effect of human probiotics on memory, psychological and biological measures in elderly: A study protocol of bi-center, double-blind, randomized, placebo-controlled clinical trial (CleverAge Biota). Front Aging Neurosci. 2022 Nov 10;14:996234. doi: 10.3389/fnagi.2022.996234. eCollection 2022.

    PubMed 36437993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probiotics C2P in people with Memory Deficits and Mood Change, run by National Institute of Mental Health, Czech Republic at 2 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months (time frame: baseline to 3 months). The study lists 72 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05051501, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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