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Sponsor: Cairo University
Conditions: Cognition Function, Mild Depression
Interventions: Lactobacillus plantarum, placebo capsule
Countries: Egypt
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.
Sex: FEMALE
Age: 50 Years to 64 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 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 Exclusion Criteria: * 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
- Cairo, Egypt