Cognition FunctionNCT07776145
Effect of Probiotic on Cognitive Function
A study testing Lactobacillus plantarum in people with Cognition Function and Mild Depression, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if daily single-strain probiotic supplementation (Lactobacillus plantarum) works to improve cognitive function and depressive symptoms in Egyptian women aged 50-64 years with mild depression. Read more about this study
- Who is it for?
- Ages 50 to 64 years, women only
- Conditions the study is for
- Cognition Function, Mild Depression
- What is being tested?
- Lactobacillus plantarum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females, aged 50-64 years
- Presence of mild depressive symptoms, defined as a Beck Depression inventory II (BDI-II) total score between 14 and 19 (inclusive) at the screening visit.
- Ability to give informed consent
Who cannot join
- Moderate and severe depression (BDI-II score > 19) or active suicidal ideation (assessed by clinical interview).
- Diagnosis of bipolar disorder, schizophrenia, or other major psychotic disorder.
- Current use of antidepressants, antipsychotics, mood stabilizers, or regular anxiolytics
- Regular consumption of probiotics, prebiotics, or synbiotic supplements within the past 4 weeks.
- Use of antibiotics or antifungals within the past 4weeks.
- Known diagnosis of inflammatory bowel disease, celiac disease, or active irritable bowel syndrome with severe symptoms.
Show all 11Show fewer
- History of significant cardiovascular disease (e.g., atrial fibrillation, heart failure, recent MI), uncontrolled hypertension, or type 1 diabetes.
- Current use of systemic hormone replacement therapy within the last 3 months.Research Template 6 Final Version: Jan 2024
- Known allergy to any component of the probiotic or placebo.
- Severe systemic illness (e.g., uncontrolled diabetes, malignancy, severe hepatic, renal disease or auto-immune diseases).
- CRP more than 10
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University (Kasr Alainy teaching hospitals)
Cairo
website@kasralainy.edu.eg
About this study
Official title: Effect of Probiotic Supplementation on Cognitive Function and Gut-Brain Axis Modulation in Females With Mild Depression
The goal of this clinical trial is to learn if daily single-strain probiotic supplementation (Lactobacillus plantarum) works to improve cognitive function and depressive symptoms in Egyptian women aged 50-64 years with mild depression. It will also learn about its effects on systemic inflammation and autonomic nervous system function via the gut-brain axis
The main questions it aims to answer are:
Read more
Does a 12-week probiotic supplementation improve cognitive function (measured by MoCA-B) compared to a placebo? Does it reduce the severity of depressive symptoms (measured by BDI-II)? Does it reduce systemic inflammation (measured by hs-CRP levels in the blood)? Does it enhance autonomic nervous system function (measured by Heart Rate Variability - HRV via a smartphone app)? Researchers will compare the probiotic capsule (Lactobacillus plantarum, 10 billion CFU) to a placebo (a look-alike capsule containing starch) to see if the probiotic works better than placebo.
Participants will:
Take one probiotic or placebo capsule orally every morning with breakfast for 12 weeks.
Visit the Family Medicine outpatient clinic at baseline and at 12 weeks for cognitive and psychological tests, HRV measurements, and blood tests.
Receive weekly follow-up messages on WhatsApp to monitor adherence and report any dietary changes or potential side effects.
Read the detailed description
Depression poses a significant global public health challenge, with women being two to three times more likely than men to develop the condition. Emerging evidence highlights a bidirectional relationship between depression, cognitive impairment, and the gut microbiota via the gut-brain axis. Dysbiosis in gut microbiota can contribute to systemic inflammation, impaired neurogenesis, and psychiatric disorders. Specific strains such as Lactobacillus plantarum have shown potential in modulating gut-brain communication, reducing inflammation, and improving neurocognitive and psychological outcomes.
This triple-blind, randomized, placebo-controlled trial aims to evaluate the efficacy of a 12-week intervention with a single-strain probiotic (Lactobacillus plantarum, 10 billion CFU daily) compared to a placebo in Egyptian women aged 50-64 years presenting with mild depressive symptoms.
Study Procedures and Flow:
Initial Screening Visit: Potential participants recruited from the Family Medicine outpatient clinics at Kasr Al-Ainy Teaching Hospitals will undergo screening. Eligibility will be confirmed by taking a comprehensive medical/psychiatric history, reviewing concomitant medications/supplements, and evaluating depressive symptoms using the Arabic validated Beck Depression Inventory-II (BDI-II, score 14-19). Eligible participants will provide written informed consent.
Baseline Assessment (Week 0): Enrolled participants will undergo baseline evaluations including:
Socio-demographic status assessment. Anthropometric measurements (weight, height, BMI). Cognitive assessment using the Arabic version of the Montreal Cognitive Assessment - Basic (MoCA-B).
Autonomic nervous system function evaluation via short-term (5-minute) resting Heart Rate Variability (HRV) measured using a smartphone-based photoplethysmography application (Welltory) under standardized conditions.
Fasting venous blood sample collection for high-sensitivity C-reactive protein (hs-CRP) level measurement.
Randomization and Intervention Phase (Weeks 1-12): Participants will be randomly allocated in a 1:1 ratio to either the probiotic or placebo group using a computer-generated permuted block design. Both intervention (probiotic) and control (placebo) capsules are identical in appearance, size, color, and packaging. Participants, assessors, and the data analyst/statistician will remain blinded throughout the study. Participants will take one capsule daily with breakfast for 12 weeks. Adherence will be monitored through weekly messaging and monthly capsule counts during study visits.
Post-Intervention Assessment (Week 12): At the end of the 12-week intervention period, participants will undergo repeat outcome assessments identical to baseline (MoCA-B, BDI-II, HRV, and fasting serum hs-CRP).
- Conditions
- Cognition Function, Mild Depression
- Being tested
- Lactobacillus plantarum, placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarumDietary supplement
Single-strain probiotic containing Lactobacillus plantarum (approximately 10 billion CFU per capsule). Manufactured by Pescado Pharmaceuticals, Cairo, Egypt. Administered as one capsule daily taken orally with breakfast for 12 weeks.
placebo capsuleOther
Placebo capsule containing inert excipients (starch), manufactured by Faculty of Pharmacy, Cairo University. Identical in appearance, size, color, and packaging to the probiotic capsule. Administered as one capsule daily taken orally with breakfast for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| probiotic group | Active comparator | Participants will receive a daily single-strain probiotic capsule containing Lactobacillus plantarum (approximately 10 billion CFU per capsule). They will take one capsule orally every morning with breakfast for a total duration of 12 weeks. Receives: Dietary Supplement: Lactobacillus plantarum |
| placebo group | Placebo comparator | Participants will receive a daily placebo capsule containing inert excipients (starch), identical in appearance, size, color, and packaging to the probiotic capsule. They will take one capsule orally every morning with breakfast for a total duration of 12 weeks. Receives: Other: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
Assessed by change in Montreal Cognitive Assessment Basic (MoCA-B) total score. MoCA-B scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline and Week 12
Change in depressive symptom severity
Assessed by change in Beck Depression Inventory-II (BDI-II) total score. BDI-II scores range from 0 to 63, with higher scores indicating higher severity of depressive symptoms.
Measured: Baseline and Week 12
Secondary outcomes (2)
Change in serum high sensitivity C-reactive protein (hs-CRP) concentration
Measured in mg/L using serum samples to evaluate systemic inflammation.
Measured: Baseline and Week 12
Change in heart rate variability (HRV)
Assessed via smartphone-based photoplethysmography application (Welltory) to evaluate autonomic nervous system regulation.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition FunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the probiotic group (Lactobacillus plantarum) or the placebo group for 12 weeks."
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Shaker Riad Girgis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776145
- Sponsor's protocol ID
- MD-144-2026
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Cognitive Function and Gut-Brain Axis Modulation in Females With Mild Depression
- ClinicalTrials.gov ID
- NCT07776145
- Acronym / sponsor ID
- MD-144-2026
- Conditions
- Cognition Function, Mild Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
The goal of this clinical trial is to learn if daily single-strain probiotic supplementation (Lactobacillus plantarum) works to improve cognitive function and depressive symptoms in Egyptian women aged 50-64 years with mild depression. It will also learn about its effects on systemic inflammation and autonomic nervous system function via the gut-brain axis
The main questions it aims to answer are:
Does a 12-week probiotic supplementation improve cognitive function (measured by MoCA-B) compared to a placebo? Does it reduce the severity of depressive symptoms (measured by BDI-II)? Does it reduce systemic inflammation (measured by hs-CRP levels in the blood)? Does it enhance autonomic nervous system function (measured by Heart Rate Variability - HRV via a smartphone app)? Researchers will compare the probiotic capsule (Lactobacillus plantarum, 10 billion CFU) to a placebo (a look-alike capsule containing starch) to see if the probiotic works better than placebo.
Participants will:
Take one probiotic or placebo capsule orally every morning with breakfast for 12 weeks.
Visit the Family Medicine outpatient clinic at baseline and at 12 weeks for cognitive and psychological tests, HRV measurements, and blood tests.
Receive weekly follow-up messages on WhatsApp to monitor adherence and report any dietary changes or potential side effects.
Detailed description
Depression poses a significant global public health challenge, with women being two to three times more likely than men to develop the condition. Emerging evidence highlights a bidirectional relationship between depression, cognitive impairment, and the gut microbiota via the gut-brain axis. Dysbiosis in gut microbiota can contribute to systemic inflammation, impaired neurogenesis, and psychiatric disorders. Specific strains such as Lactobacillus plantarum have shown potential in modulating gut-brain communication, reducing inflammation, and improving neurocognitive and psychological outcomes.
This triple-blind, randomized, placebo-controlled trial aims to evaluate the efficacy of a 12-week intervention with a single-strain probiotic (Lactobacillus plantarum, 10 billion CFU daily) compared to a placebo in Egyptian women aged 50-64 years presenting with mild depressive symptoms.
Study Procedures and Flow:
Initial Screening Visit: Potential participants recruited from the Family Medicine outpatient clinics at Kasr Al-Ainy Teaching Hospitals will undergo screening. Eligibility will be confirmed by taking a comprehensive medical/psychiatric history, reviewing concomitant medications/supplements, and evaluating depressive symptoms using the Arabic validated Beck Depression Inventory-II (BDI-II, score 14-19). Eligible participants will provide written informed consent.
Baseline Assessment (Week 0): Enrolled participants will undergo baseline evaluations including:
Socio-demographic status assessment. Anthropometric measurements (weight, height, BMI). Cognitive assessment using the Arabic version of the Montreal Cognitive Assessment - Basic (MoCA-B).
Autonomic nervous system function evaluation via short-term (5-minute) resting Heart Rate Variability (HRV) measured using a smartphone-based photoplethysmography application (Welltory) under standardized conditions.
Fasting venous blood sample collection for high-sensitivity C-reactive protein (hs-CRP) level measurement.
Randomization and Intervention Phase (Weeks 1-12): Participants will be randomly allocated in a 1:1 ratio to either the probiotic or placebo group using a computer-generated permuted block design. Both intervention (probiotic) and control (placebo) capsules are identical in appearance, size, color, and packaging. Participants, assessors, and the data analyst/statistician will remain blinded throughout the study. Participants will take one capsule daily with breakfast for 12 weeks. Adherence will be monitored through weekly messaging and monthly capsule counts during study visits.
Post-Intervention Assessment (Week 12): At the end of the 12-week intervention period, participants will undergo repeat outcome assessments identical to baseline (MoCA-B, BDI-II, HRV, and fasting serum hs-CRP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the probiotic group (Lactobacillus plantarum) or the placebo group for 12 weeks."
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Active comparator | Dietary Supplement: Lactobacillus plantarumParticipants will receive a daily single-strain probiotic capsule containing Lactobacillus plantarum (approximately 10 billion CFU per capsule). They will take one capsule orally every morning with breakfast for a total duration of 12 weeks. |
| placebo group | Placebo comparator | Other: placebo capsuleParticipants will receive a daily placebo capsule containing inert excipients (starch), identical in appearance, size, color, and packaging to the probiotic capsule. They will take one capsule orally every morning with breakfast for a total duration of 12 weeks. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females, aged 50-64 years
- Presence of mild depressive symptoms, defined as a Beck Depression inventory II (BDI-II) total score between 14 and 19 (inclusive) at the screening visit.
- Ability to give informed consent
Key exclusion criteria (11 listed)
- Moderate and severe depression (BDI-II score > 19) or active suicidal ideation (assessed by clinical interview).
- Diagnosis of bipolar disorder, schizophrenia, or other major psychotic disorder.
- Current use of antidepressants, antipsychotics, mood stabilizers, or regular anxiolytics
- Regular consumption of probiotics, prebiotics, or synbiotic supplements within the past 4 weeks.
- Use of antibiotics or antifungals within the past 4weeks.
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 plantarumSingle-strain probiotic containing Lactobacillus plantarum (approximately 10 billion CFU per capsule). Manufactured by Pescado Pharmaceuticals, Cairo, Egypt. Administered as one capsule daily taken orally with breakfast for 12 weeks. | Dietary supplement | probiotic group |
| placebo capsulePlacebo capsule containing inert excipients (starch), manufactured by Faculty of Pharmacy, Cairo University. Identical in appearance, size, color, and packaging to the probiotic capsule. Administered as one capsule daily taken orally with breakfast for 12 weeks. | Other | placebo group |
Primary outcome
Change in cognitive function
Time frame: Baseline and Week 12
Assessed by change in Montreal Cognitive Assessment Basic (MoCA-B) total score. MoCA-B scores range from 0 to 30, with higher scores indicating better cognitive performance.
Change in depressive symptom severity
Time frame: Baseline and Week 12
Assessed by change in Beck Depression Inventory-II (BDI-II) total score. BDI-II scores range from 0 to 63, with higher scores indicating higher severity of depressive symptoms.
2 secondary outcomes
Change in serum high sensitivity C-reactive protein (hs-CRP) concentration
Time frame: Baseline and Week 12
Change in heart rate variability (HRV)
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum in people with Cognition Function and Mild Depression, run by Cairo University at 1 site in Egypt.
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 11 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina S Girgis, MD (02-1287128004, marina.riad38728@postgrad.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.