An interventional study of Lactobacillus plantarum and placebo capsule in Cognition Function and Mild Depression, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 50 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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Among 20 studies in Depression by Cairo University — 7 open to participants now, 7 under way, none of them phase 3. Depression · Cairo University.
Among the 20 studies in Depression by Cairo University, this one is the 3rd largest by planned enrollment of the 17 interventional ones that give a count, is one of 5 that started in 2026, is one of 16 with no phase, and was the 20th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →7 of the 20 studies in Depression by Cairo University are open now, in 1 country. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 18–60
Cairo University · Sites in Egypt
Ages 35–55
Cairo University · Sites in Egypt
Ages 30–60 · Healthy volunteers
Cairo University
Ages 13–18 · Women only
Cairo University · Sites in Egypt
Ages 25–50
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 50 Years to 64 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 88 is close to the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 50 across the 17 interventional studies, 85 across the 3 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
3 of the studies in Depression by Cairo University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07452341Cairo UniversityEffect of Virtual Reality on Depression in Adolescent Females | 2027-01-01 |
| NCT07776145Cairo UniversityEffect of Probiotic on Cognitive Function | 2027-09 |
| NCT07600411Cairo UniversityBinge Eating, Depression and Anxiety Outcomes After Sleeve Gastrectomy Versus Gastric Bypass: A Cohort Study | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 20 studies in Depression by Cairo University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females, aged 50-64 years
Exclusion Criteria:
Current use of antidepressants, antipsychotics, mood stabilizers, or regular anxiolytics
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Lactobacillus plantarum
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.
Other: placebo capsule
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 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.
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.
Time frame: 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.
Time frame: Baseline and Week 12
Change in serum high sensitivity C-reactive protein (hs-CRP) concentration
Measured in mg/L using serum samples to evaluate systemic inflammation.
Time frame: Baseline and Week 12
Change in heart rate variability (HRV)
Assessed via smartphone-based photoplethysmography application (Welltory) to evaluate autonomic nervous system regulation.
Time frame: Baseline and Week 12
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lactobacillus plantarum