Depressive SymptomsProBrain01NCT03478527
Probiotics, Brain Structure and Psychological Variables
A study testing Vivomixx® powder in people with Depressive Symptoms and Anxiety, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Theory and research on the gut-brain-axis emphasize complex interactions between the gut microbiota, immunological and hormonal responses, brain function, brain structure, as well as resulting behavioral manifestations, such as cognitive functions and mental illness. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety, Stress
- What is being tested?
- Vivomixx® powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2018to 28 Jan 2021
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants
- age 18-40
- informed consent for all parts of the study (including MRT)
- none of the exclusion criteria (see below) fulfilled
Who cannot join
- age < 18 or > 40 years
- pregnancy or breastfeeding
- left-handedness
- degenerative or inflammatory diseases of the central nervous system
- severe cognitive/ neuropsychological impairment
- severe pain syndrome or other severe organic diseases
Show all 32Show fewer
- epilepsy
- (past or present) psychiatric disorders
- neurological disorder
- severe diabetic polyneuropathy
- malignancies/ cancer
- cardiac insufficiency
- arterial hypertension
- heart attack/ stroke
- severe hepatic or renal insufficiency
- diseases of the hemopoietic system
- alcoholism/ drug addiction
- medical history of severe allergic or toxic reactions
- current participation in drug trial
- doubts about legal capacity/ capability of understanding
- referral to institutions based on court/ official order
- treatment with centrally acting medication (e.g. antipsychotics, antiepileptics, antidepressants, etc.)
- non-removable metal pieces (aneurysm clips, artificial limbs, etc.) or implanted electronic devices (pacemaker, osmotic or other implanted pumps, cochlear implants, etc.)
- claustrophobia
- acute (respiratory) infection, physical uneasiness
- tattoos in the head region, permanent make-up
- non-removable piercings
- chronic/ acute gastrointestinal diseases
- vegetarianism, veganism
- current intake of antibiotics or intake of antibiotics at any time point during the last 2 months
- lactose intolerance
- general focus on probiotic diet
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Hamburg, 20246
About this study
Official title: Effects of Probiotic Bacteria on Brain Structure and Function and on Psychological Variables
Theory and research on the gut-brain-axis emphasize complex interactions between the gut microbiota, immunological and hormonal responses, brain function, brain structure, as well as resulting behavioral manifestations, such as cognitive functions and mental illness. Probiotics are living micro-organisms that change the composition of the gut microbiota and hypothetically have a positive effect on the host's general health and well-being. Probiotic bacteria naturally occur in foods such as Sauerkraut, olives, and dark chocolate, and are currently also added to industrial products such as yogurt.
Regarding the effect of probiotics on brain structure and function, animal studies have shown that the administration of probiotics in mice and rats was linked to neurogenesis in the hippocampus and an improvement of associated cognitive functions. The majority of these studies applied probiotics for 4 weeks. The substances used in these studies were often composed of several bacterial strains, suggesting that the neurogenic effect may not be reducible to a specific type of probiotic bacteria.
Read more
Probiotics seem to be effective in improving memory abilities, including spatial and non-spatial memory, both in rodents and humans. Moreover, specifically regarding the beneficial effect of probiotics on anxiety, depression and stress, preliminary evidence in humans is compelling. However methodologically sound (randomized-controlled trial [RCT], 'blind') studies are still lacking.
To sum up, the present study is going to be the first RCT with human participants that investigates structural and functional changes of the hippocampus through probiotic bacteria, using Magnet Resonance Imaging (MRI). In addition, the study aims at advancing research in the field by investigating the effects of probiotics on a broad spectrum of cognitive functions, particularly those associated with hippocampal activity (e.g. spatial memory, verbal memory). Furthermore, effects on several types of mental illness (e.g. anxiety, depression, stress) will be studied. Potential translatory mechanisms that may promote the aforementioned effects will be examined, i.e. changes in immunological parameters, 'brain derived neurotrophic factor' (BDNF), and oxytocin.
Read the detailed description
A double-blind RCT intervention study will be conducted to investigate the effect of a probiotic dietary supplement vs. a placebo, taken by healthy human participants (N = 60) for 28 consecutive days. Both substances are administered in doses of 4.4g (powder) per day.
The probiotic dietary supplement used in the present study is a freely available product (in powder form) sold under the name of Vivomixx®. Per 4.4g the powder contains 450 billion bacteria, composed of eight bacterial strains: Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L.delbrueckii subsp. bulgaricus), Bifidobacteria (B. longum, B. infantis, B. breve), and Streptococcus thermophiles.
This product was chosen, because a similar supplement with an identical composition of bacteria as Vivomixx® was found to be linked to hippocampal neurogenesis in mice. The placebo powder has a similar taste and consistency as the verum (Vivomixx®) powder, but contains no probiotic bacteria.
First, participants will be screened online for eligibility (T0). Before and after the 28-day intake period, participants are asked to perform several cognitive tests and fill out questionnaires (T1, T2) at our laboratory (ca. 2 - 2.5 hours). Afterwards, blood samples will be drawn (ca. 5 minutes) and a magnet resonance tomography (MRT) session (ca. 1 - 1.5 hours) will be conducted, where participants will perform an object pattern separation task in the scanner (T1, T2). Furthermore, a follow-up after 2 months (T3), including the same assessments as at T1 and T2, will be conducted.
During the intake period participants will fill out a brief questionnaire on a weekly basis, which includes an assessment of state depression and anxiety, defecation (control item to rule out adverse effects), recent (start of) intake of medication, recent (onset of) intake of antibiotics, and recent inter-current illness (e.g. influenza). In addition, participants will record their food intake (protocol) for one week (7 consecutive days) during the intake period.
- Conditions
- Depressive Symptoms, Anxiety, Stress
- Being tested
- Vivomixx® powder, Placebo powder
- Keywords
- Probiotics, Psychiatric Symptoms, Cognitive Function, Hippocampus, Oxytocin, Immunological Parameters
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivomixx® powderDietary supplement
Also called probiotic dietary supplement
Participants will take in a daily dose of 4.4g for 28 consecutive days
Placebo powderOther
Participants will take in a daily dose of 4.4g for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| verum condition probiotics | Experimental | The verum condition probiotics in the present study is a freely available product, Vivomixx® powder (dietary supplement). Each dose (4.4g) contains 450 billion bacteria, composed of eight bacterial strains: Lactobacilli (L. paracasei, L. plantarum, L. acidophilus, L.delbrueckii subsp. bulgaricus), Bifidobacteria (B. longum, B. infantis, B. breve), and Streptococcus thermophiles. 30 Participants will be randomly assigned to this condition. The intake period is 28 days, daily dose = 4.4g. Receives: Dietary Supplement: Vivomixx® powder |
| placebo condition | Placebo comparator | In the placebo condition participants will receive a placebo powder (comparable in taste and consistency to Vivomixx® = verum condition probiotics) that contains no probiotic bacteria. 30 Participants will be randomly assigned to that condition. The intake period is 28 days, daily dose = 4.4g. Receives: Other: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hippocampal volume, assessed via Magnet Resonance Imaging (MRI)
changes in hippocampal volume in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in functional brain activation during fMRI task
changes in functional connectivity (using BOLD signal) in hippocampal regions in verum experimental group (in comparison to placebo control) during pattern separation fMRI task
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in depression
changes in levels of depression, assessed with Beck's Depression Inventory - II Revised (BDI-II-R) sum score in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in spatial navigation
changes in test performance scores (number of correct responses, degree of accuracy measured as position hits) in the Tunnel task in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Interleukin-6 (IL-6)
changes in IL-6 blood serum concentration levels in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in IL-1ß
changes in IL-1ß blood serum concentration levels in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Tumor Necrosis Factor alpha (TNF-alpha)
changes in TNF-alpha blood serum concentration levels in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in Brain Derived Neurotrophic Factor (BDNF)
changes in blood serum level concentration of BDNF in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in verbal learning test performance
changes in verbal learning performance score, assessed with the Verbal Learning Memory Test (VLMT) in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Changes in pattern separation fMRI task
changes in the pattern separation task performance (no. of correct responses to picture stimuli) in in verum experimental group (in comparison to placebo control)
Measured: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 Jan 2018
- Primary completion30 Nov 2019
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 Verum group, receiving the probiotic Vivomixx® powder 1 Placebo group, receiving a placebo powder (similar taste and consistency as Vivomixx® powder)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Kühn, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, UKE Martinistraße 52, 20246 Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478527
- Sponsor's protocol ID
- ProBrain01
- Acronym
- ProBrain01
- Status last verified
- Feb 2021
- First submitted
- 26 Jan 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buffington SA, Di Prisco GV, Auchtung TA, Ajami NJ, Petrosino JF, Costa-Mattioli M. Microbial Reconstitution Reverses Maternal Diet-Induced Social and Synaptic Deficits in Offspring. Cell. 2016 Jun 16;165(7):1762-1775. doi: 10.1016/j.cell.2016.06.001.
PubMed 27315483El Aidy S, Dinan TG, Cryan JF. Immune modulation of the brain-gut-microbe axis. Front Microbiol. 2014 Apr 7;5:146. doi: 10.3389/fmicb.2014.00146. eCollection 2014. No abstract available.
PubMed 24778631Foster JA, McVey Neufeld KA. Gut-brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013 May;36(5):305-12. doi: 10.1016/j.tins.2013.01.005. Epub 2013 Feb 4.
PubMed 23384445Liu J, Sun J, Wang F, Yu X, Ling Z, Li H, Zhang H, Jin J, Chen W, Pang M, Yu J, He Y, Xu J. Neuroprotective Effects of Clostridium butyricum against Vascular Dementia in Mice via Metabolic Butyrate. Biomed Res Int. 2015;2015:412946. doi: 10.1155/2015/412946. Epub 2015 Oct 7.
PubMed 26523278Liu WH, Chuang HL, Huang YT, Wu CC, Chou GT, Wang S, Tsai YC. Alteration of behavior and monoamine levels attributable to Lactobacillus plantarum PS128 in germ-free mice. Behav Brain Res. 2016 Feb 1;298(Pt B):202-9. doi: 10.1016/j.bbr.2015.10.046. Epub 2015 Oct 29.
PubMed 26522841Mohle L, Mattei D, Heimesaat MM, Bereswill S, Fischer A, Alutis M, French T, Hambardzumyan D, Matzinger P, Dunay IR, Wolf SA. Ly6C(hi) Monocytes Provide a Link between Antibiotic-Induced Changes in Gut Microbiota and Adult Hippocampal Neurogenesis. Cell Rep. 2016 May 31;15(9):1945-56. doi: 10.1016/j.celrep.2016.04.074. Epub 2016 May 19.
PubMed 27210745Wallace CJK, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann Gen Psychiatry. 2017 Feb 20;16:14. doi: 10.1186/s12991-017-0138-2. eCollection 2017.
PubMed 28239408Wang H, Lee IS, Braun C, Enck P. Effect of Probiotics on Central Nervous System Functions in Animals and Humans: A Systematic Review. J Neurogastroenterol Motil. 2016 Oct 30;22(4):589-605. doi: 10.5056/jnm16018.
PubMed 27413138
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Bacteria on Brain Structure and Function and on Psychological Variables
- ClinicalTrials.gov ID
- NCT03478527
- Acronym / sponsor ID
- ProBrain01 / ProBrain01
- Conditions
- Depressive Symptoms, Anxiety, Stress
- Keywords
- Probiotics, Psychiatric Symptoms, Cognitive Function, Hippocampus, Oxytocin, Immunological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Theory and research on the gut-brain-axis emphasize complex interactions between the gut microbiota, immunological and hormonal responses, brain function, brain structure, as well as resulting behavioral manifestations, such as cognitive functions and mental illness. Probiotics are living micro-organisms that change the composition of the gut microbiota and hypothetically have a positive effect on the host's general health and well-being. Probiotic bacteria naturally occur in foods such as Sauerkraut, olives, and dark chocolate, and are currently also added to industrial products such as yogurt.
Regarding the effect of probiotics on brain structure and function, animal studies have shown that the administration of probiotics in mice and rats was linked to neurogenesis in the hippocampus and an improvement of associated cognitive functions. The majority of these studies applied probiotics for 4 weeks. The substances used in these studies were often composed of several bacterial strains, suggesting that the neurogenic effect may not be reducible to a specific type of probiotic bacteria.
Probiotics seem to be effective in improving memory abilities, including spatial and non-spatial memory, both in rodents and humans. Moreover, specifically regarding the beneficial effect of probiotics on anxiety, depression and stress, preliminary evidence in humans is compelling. However methodologically sound (randomized-controlled trial [RCT], 'blind') studies are still lacking.
To sum up, the present study is going to be the first RCT with human participants that investigates structural and functional changes of the hippocampus through probiotic bacteria, using Magnet Resonance Imaging (MRI). In addition, the study aims at advancing research in the field by investigating the effects of probiotics on a broad spectrum of cognitive functions, particularly those associated with hippocampal activity (e.g. spatial memory, verbal memory). Furthermore, effects on several types of mental illness (e.g. anxiety, depression, stress) will be studied. Potential translatory mechanisms that may promote the aforementioned effects will be examined, i.e. changes in immunological parameters, 'brain derived neurotrophic factor' (BDNF), and oxytocin.
Detailed description
A double-blind RCT intervention study will be conducted to investigate the effect of a probiotic dietary supplement vs. a placebo, taken by healthy human participants (N = 60) for 28 consecutive days. Both substances are administered in doses of 4.4g (powder) per day.
The probiotic dietary supplement used in the present study is a freely available product (in powder form) sold under the name of Vivomixx®. Per 4.4g the powder contains 450 billion bacteria, composed of eight bacterial strains: Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L.delbrueckii subsp. bulgaricus), Bifidobacteria (B. longum, B. infantis, B. breve), and Streptococcus thermophiles.
This product was chosen, because a similar supplement with an identical composition of bacteria as Vivomixx® was found to be linked to hippocampal neurogenesis in mice. The placebo powder has a similar taste and consistency as the verum (Vivomixx®) powder, but contains no probiotic bacteria.
First, participants will be screened online for eligibility (T0). Before and after the 28-day intake period, participants are asked to perform several cognitive tests and fill out questionnaires (T1, T2) at our laboratory (ca. 2 - 2.5 hours). Afterwards, blood samples will be drawn (ca. 5 minutes) and a magnet resonance tomography (MRT) session (ca. 1 - 1.5 hours) will be conducted, where participants will perform an object pattern separation task in the scanner (T1, T2). Furthermore, a follow-up after 2 months (T3), including the same assessments as at T1 and T2, will be conducted.
During the intake period participants will fill out a brief questionnaire on a weekly basis, which includes an assessment of state depression and anxiety, defecation (control item to rule out adverse effects), recent (start of) intake of medication, recent (onset of) intake of antibiotics, and recent inter-current illness (e.g. influenza). In addition, participants will record their food intake (protocol) for one week (7 consecutive days) during the intake period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1 Verum group, receiving the probiotic Vivomixx® powder 1 Placebo group, receiving a placebo powder (similar taste and consistency as Vivomixx® powder)
| Arm | Type | Receives |
|---|---|---|
| verum condition probiotics | Experimental | Dietary Supplement: Vivomixx® powderThe verum condition probiotics in the present study is a freely available product, Vivomixx® powder (dietary supplement). Each dose (4.4g) contains 450 billion bacteria, composed of eight bacterial strains: Lactobacilli (L. paracasei, L. plantarum, L. acidophilus, L.delbrueckii subsp. bulgaricus), Bifidobacteria (B. longum, B. infantis, B. breve), and Streptococcus thermophiles. 30 Participants will be randomly assigned to this condition. The intake period is 28 days, daily dose = 4.4g. |
| placebo condition | Placebo comparator | Other: Placebo powderIn the placebo condition participants will receive a placebo powder (comparable in taste and consistency to Vivomixx® = verum condition probiotics) that contains no probiotic bacteria. 30 Participants will be randomly assigned to that condition. The intake period is 28 days, daily dose = 4.4g. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy participants
- age 18-40
- informed consent for all parts of the study (including MRT)
- none of the exclusion criteria (see below) fulfilled
Key exclusion criteria (32 listed)
- age < 18 or > 40 years
- pregnancy or breastfeeding
- left-handedness
- degenerative or inflammatory diseases of the central nervous system
- severe cognitive/ neuropsychological impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivomixx® powderAlso: probiotic dietary supplementParticipants will take in a daily dose of 4.4g for 28 consecutive days | Dietary supplement | verum condition probiotics |
| Placebo powderParticipants will take in a daily dose of 4.4g for 28 consecutive days | Other | placebo condition |
Primary outcome
Changes in hippocampal volume, assessed via Magnet Resonance Imaging (MRI)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in hippocampal volume in verum experimental group (in comparison to placebo control)
Changes in functional brain activation during fMRI task
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in functional connectivity (using BOLD signal) in hippocampal regions in verum experimental group (in comparison to placebo control) during pattern separation fMRI task
Changes in depression
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in levels of depression, assessed with Beck's Depression Inventory - II Revised (BDI-II-R) sum score in verum experimental group (in comparison to placebo control)
Changes in spatial navigation
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in test performance scores (number of correct responses, degree of accuracy measured as position hits) in the Tunnel task in verum experimental group (in comparison to placebo control)
Changes in Interleukin-6 (IL-6)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in IL-6 blood serum concentration levels in verum experimental group (in comparison to placebo control)
Changes in IL-1ß
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in IL-1ß blood serum concentration levels in verum experimental group (in comparison to placebo control)
Changes in Tumor Necrosis Factor alpha (TNF-alpha)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in TNF-alpha blood serum concentration levels in verum experimental group (in comparison to placebo control)
Changes in Brain Derived Neurotrophic Factor (BDNF)
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in blood serum level concentration of BDNF in verum experimental group (in comparison to placebo control)
Changes in verbal learning test performance
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in verbal learning performance score, assessed with the Verbal Learning Memory Test (VLMT) in verum experimental group (in comparison to placebo control)
Changes in pattern separation fMRI task
Time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)
changes in the pattern separation task performance (no. of correct responses to picture stimuli) in in verum experimental group (in comparison to placebo control)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 27315483Buffington SA, Di Prisco GV, Auchtung TA, Ajami NJ, Petrosino JF, Costa-Mattioli M. Microbial Reconstitution Reverses Maternal Diet-Induced Social and Synaptic Deficits in Offspring. Cell. 2016 Jun 16;165(7):1762-1775. doi: 10.1016/j.cell.2016.06.001.
- Background: PubMed 24778631El Aidy S, Dinan TG, Cryan JF. Immune modulation of the brain-gut-microbe axis. Front Microbiol. 2014 Apr 7;5:146. doi: 10.3389/fmicb.2014.00146. eCollection 2014. No abstract available.
- Background: PubMed 23384445Foster JA, McVey Neufeld KA. Gut-brain axis: how the microbiome influences anxiety and depression. Trends Neurosci. 2013 May;36(5):305-12. doi: 10.1016/j.tins.2013.01.005. Epub 2013 Feb 4.
- Background: PubMed 26523278Liu J, Sun J, Wang F, Yu X, Ling Z, Li H, Zhang H, Jin J, Chen W, Pang M, Yu J, He Y, Xu J. Neuroprotective Effects of Clostridium butyricum against Vascular Dementia in Mice via Metabolic Butyrate. Biomed Res Int. 2015;2015:412946. doi: 10.1155/2015/412946. Epub 2015 Oct 7.
- Background: PubMed 26522841Liu WH, Chuang HL, Huang YT, Wu CC, Chou GT, Wang S, Tsai YC. Alteration of behavior and monoamine levels attributable to Lactobacillus plantarum PS128 in germ-free mice. Behav Brain Res. 2016 Feb 1;298(Pt B):202-9. doi: 10.1016/j.bbr.2015.10.046. Epub 2015 Oct 29.
- Background: PubMed 27210745Mohle L, Mattei D, Heimesaat MM, Bereswill S, Fischer A, Alutis M, French T, Hambardzumyan D, Matzinger P, Dunay IR, Wolf SA. Ly6C(hi) Monocytes Provide a Link between Antibiotic-Induced Changes in Gut Microbiota and Adult Hippocampal Neurogenesis. Cell Rep. 2016 May 31;15(9):1945-56. doi: 10.1016/j.celrep.2016.04.074. Epub 2016 May 19.
- Background: PubMed 28239408Wallace CJK, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann Gen Psychiatry. 2017 Feb 20;16:14. doi: 10.1186/s12991-017-0138-2. eCollection 2017.
- Background: PubMed 27413138Wang H, Lee IS, Braun C, Enck P. Effect of Probiotics on Central Nervous System Functions in Animals and Humans: A Systematic Review. J Neurogastroenterol Motil. 2016 Oct 30;22(4):589-605. doi: 10.5056/jnm16018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Kühn, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, UKE Martinistraße 52, 20246 Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivomixx® powder in people with Depressive Symptoms and Anxiety, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 32 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in hippocampal volume, assessed via Magnet Resonance Imaging (MRI) (time frame: at baseline (day 0) after intake period (day 28+) and at follow up (day 84+)). The study lists 10 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 NCT03478527, which also lists 8 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 9 Feb 2021.