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Effect of Probiotic on Cognitive Function
Sponsor: Cairo University
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.
Official title: Effect of Probiotic Supplementation on Cognitive Function and Gut-Brain Axis Modulation in Females With Mild Depression
Key Details
Gender
FEMALE
Age Range
50 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2026-09
Completion Date
2027-10
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Cairo University (Kasr Alainy teaching hospitals)
Cairo, Egypt