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Effect of Probiotic on Cognitive Function

NCT07776145 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-08-20

No results posted yet for this study

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. 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.

Conditions

  • Cognition Function
  • Mild Depression

Interventions

DIETARY_SUPPLEMENT

Lactobacillus plantarum

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.

OTHER

placebo capsule

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776145 on ClinicalTrials.gov