HealthyNCT04828421
The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects
A study testing Lactobacillus rhamnosus and Bifidobacterium lactis in people with Healthy, run by Universidad de Almeria at 3 sites in Spain.
Trial summary
This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients. Read more about this study
- Who is it for?
- Ages 56 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus rhamnosus and Bifidobacterium lactis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesSpain
- Study dates
- 17 Jul 2020to 30 Apr 2022
- 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 56 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be aged 55 years or over,
- voluntarily agree to participate in the study in accordance with the Helsinki declaration,
- not be participating in another study that could interfere with the results.
Who cannot join
- suffer from any serious mental illness other than depression and anxiety,
- score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
- be using medications that affect cognition,
- taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
- have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Universidad de Almeria
Almería, Almeria, 04120
Pablo Roman
Almería, 04120
Universidad de Almeria
La Cañada de San Urbano, Almeria, 04120
About this study
Official title: The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial
This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.
Read the detailed description
Gut microbiota (GM) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered GM such as elderly population as age-related changes. Several studies have shown that ageing alter GM, both in diversity and integrity.
Probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components.
The aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. The hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.
- Conditions
- Healthy
- Being tested
- Lactobacillus rhamnosus and Bifidobacterium lactis, Placebo
- Keywords
- Probiotics, Cognitive, Emotional, Aging, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus and Bifidobacterium lactisDietary supplement
Probiotics
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks. Receives: Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis |
| Placebo group | Placebo comparator | Participants will receive a harmless substance (potato starch) during 10 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Anxiety at 10 weeks
The State-Trait Anxiety Inventory. Score range: 20-80
Measured: Before and after treatment (10 weeks)
Change from Baseline Depression at 10 weeks
The Beck Depression Inventory. Score range: 0-63.
Measured: Before and after treatment (10 weeks)
Change from Baseline General Cognitive Status at 10 weeks
Mini-Mental State Examination. Score range: 0-35
Measured: Before and after treatment (10 weeks)
Change from Baseline Working Memory at 10 weeks
Digits task, Corsi task
Measured: Before and after treatment (10 weeks)
Change from Baseline Planning Ability at 10 weeks
Tower of London test
Measured: Before and after treatment (10 weeks)
Change from Baseline Problem-solving ability at 10 weeks
Wisconsin Card Sorting test
Measured: Before and after treatment (10 weeks)
Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
Stroop task
Measured: Before and after treatment (10 weeks)
Change from Baseline Visual Attention at 10 weeks
Trail Making Test
Measured: Before and after treatment (10 weeks)
Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
Go/No-Go task
Measured: Before and after treatment (10 weeks)
Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
Iowa Gambling Task
Measured: Before and after treatment (10 weeks)
Secondary outcomes (8)
Change from Baseline Food Habits at 10 weeks
"24-hour recall" questionnaire
Measured: Before and after treatment (10 weeks)
Change from Baseline Alcohol Use at 10 weeks
The Alcohol Use Disorders Identification Test. Score range: 0-40
Measured: Before and after treatment (10 weeks)
Change from Baseline Body Composition at 10 weeks
Fat mass. Body fat mass. Fat-free mass. Total body water.
Measured: Before and after treatment (10 weeks)
Change from Baseline Physical Activity at 10 weeks
International Physical Activity Questionnaire
Measured: Before and after treatment (10 weeks)
Change from Baseline Stool Consistency at 10 weeks
The Bristol Scale
Measured: Before and after treatment (10 weeks)
Change from Baseline Sleep Quality at 10 weeks
The Pittsburgh Sleep Quality Index Questionnaire. Score range: 0-21
Measured: Before and after treatment (10 weeks)
Change from Baseline Perceived Stress at 10 weeks
Perceived Stress Questionnaire. Score range: 0-1
Measured: Before and after treatment (10 weeks)
Change from Baseline Gastrointestinal Symptom at 10 weeks
Gastrointestinal Symptom Rating Scale
Measured: Before and after treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start17 Jul 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Román López, Universidad de Almeria
- Investigators
- PABLO R LOPEZ, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828421
- Sponsor's protocol ID
- UALBIO2020/001
- Status last verified
- May 2022
- First submitted
- 29 Mar 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz-Gonzalez C, Cardona D, Rueda-Ruzafa L, Rodriguez-Arrastia M, Ropero-Padilla C, Roman P. Cognitive and Emotional Effect of a Multi-species Probiotic Containing Lactobacillus rhamnosus and Bifidobacterium lactis in Healthy Older Adults: A Double-Blind Randomized Placebo-Controlled Crossover Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3525-3537. doi: 10.1007/s12602-024-10315-2. Epub 2024 Jun 27.
PubMed 38935259
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects: a Randomized, Double-blind, Cross-over and Controlled Trial
- ClinicalTrials.gov ID
- NCT04828421
- Acronym / sponsor ID
- UALBIO2020/001
- Conditions
- Healthy
- Keywords
- Probiotics, Cognitive, Emotional, Aging, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Apr 2021 (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.
This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.
Detailed description
Gut microbiota (GM) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered GM such as elderly population as age-related changes. Several studies have shown that ageing alter GM, both in diversity and integrity.
Probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components.
The aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. The hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactisParticipants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive a harmless substance (potato starch) during 10 weeks. |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be aged 55 years or over,
- voluntarily agree to participate in the study in accordance with the Helsinki declaration,
- not be participating in another study that could interfere with the results.
Key exclusion criteria (5 listed)
- suffer from any serious mental illness other than depression and anxiety,
- score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
- be using medications that affect cognition,
- taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
- have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).
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 |
|---|---|---|
| Lactobacillus rhamnosus and Bifidobacterium lactisProbiotics | Dietary supplement | Probiotic group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
Change from Baseline Anxiety at 10 weeks
Time frame: Before and after treatment (10 weeks)
The State-Trait Anxiety Inventory. Score range: 20-80
Change from Baseline Depression at 10 weeks
Time frame: Before and after treatment (10 weeks)
The Beck Depression Inventory. Score range: 0-63.
Change from Baseline General Cognitive Status at 10 weeks
Time frame: Before and after treatment (10 weeks)
Mini-Mental State Examination. Score range: 0-35
Change from Baseline Working Memory at 10 weeks
Time frame: Before and after treatment (10 weeks)
Digits task, Corsi task
Change from Baseline Planning Ability at 10 weeks
Time frame: Before and after treatment (10 weeks)
Tower of London test
Change from Baseline Problem-solving ability at 10 weeks
Time frame: Before and after treatment (10 weeks)
Wisconsin Card Sorting test
Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks
Time frame: Before and after treatment (10 weeks)
Stroop task
Change from Baseline Visual Attention at 10 weeks
Time frame: Before and after treatment (10 weeks)
Trail Making Test
Change from Baseline Motor impulsivity or inhibitory response at 10 weeks
Time frame: Before and after treatment (10 weeks)
Go/No-Go task
Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks
Time frame: Before and after treatment (10 weeks)
Iowa Gambling Task
8 secondary outcomes
Change from Baseline Food Habits at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Alcohol Use at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Body Composition at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Physical Activity at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Stool Consistency at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Sleep Quality at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Perceived Stress at 10 weeks
Time frame: Before and after treatment (10 weeks)
Change from Baseline Gastrointestinal Symptom at 10 weeks
Time frame: Before and after treatment (10 weeks)
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 1 Jun 2022.
- Derived from this study: PubMed 38935259Ruiz-Gonzalez C, Cardona D, Rueda-Ruzafa L, Rodriguez-Arrastia M, Ropero-Padilla C, Roman P. Cognitive and Emotional Effect of a Multi-species Probiotic Containing Lactobacillus rhamnosus and Bifidobacterium lactis in Healthy Older Adults: A Double-Blind Randomized Placebo-Controlled Crossover Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3525-3537. doi: 10.1007/s12602-024-10315-2. Epub 2024 Jun 27.
- 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.
PABLO R LOPEZ principal investigator
Universidad de Almeria
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus and Bifidobacterium lactis in people with Healthy, run by Universidad de Almeria at 3 sites in Spain.
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 3 inclusion and 5 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 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Change from Baseline Anxiety at 10 weeks (time frame: Before and after treatment (10 weeks)). 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 NCT04828421, which also lists 1 linked publication.
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 2022.