NCT07776145

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Sep 2026Oct 2027

First Submitted

Initial submission to the registry

August 2, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 2, 2026

Last Update Submit

August 18, 2026

Conditions

Cognition FunctionMild Depression

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and Week 12

Secondary Outcomes (2)

  • Change in serum high sensitivity C-reactive protein (hs-CRP) concentration

    Baseline and Week 12

  • Change in heart rate variability (HRV)

    Baseline and Week 12

Study Arms (2)

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.

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.

Other: placebo capsule

Interventions

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.

probiotic group
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.

placebo group

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly female participants are eligible for inclusion in this study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University (Kasr Alainy teaching hospitals)

Cairo, Egypt

Location

Central Study Contacts

Marina S Girgis, MD

CONTACT

02-1287128004marina.riad38728@postgrad.kasralainy.edu.eg

Rehab H Mahmoud

CONTACT

02-1015772989Rehab.m@residents.kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
"This is a triple-blind trial where participants, assessors/care providers, and the statistician analyzing the dataset are all blinded to group allocation."
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a 1:1 ratio to either the probiotic group (Lactobacillus plantarum) or the placebo group for 12 weeks."
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 20, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)