Effect of Probiotic on Cognitive Function
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-64
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Regular consumption of probiotics, prebiotics, or synbiotic supplements within the past 4 weeks.
Use of antibiotics or antifungals within the past 4weeks.
Trial design
Design model
Parallel
Treatments tested in this trial
Lactobacillus plantarum
Dietary supplementSingle-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
Other interventionPlacebo 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: probiotic groupActive comparator 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 122
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 12Secondary outcomes
1
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 122
Change in heart rate variability (HRV)
Assessed via smartphone-based photoplethysmography application (Welltory) to evaluate autonomic nervous system regulation.
Time frame
Baseline and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: