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Effect of Psychobiotics With Standard Antiddepressants in Treatment of Major Depressive Disorder
Sponsor: Dr Sadia yasir
Summary
The goal of this clinical trial is to learn whether adding psychobiotics (a combination of Lactobacillus helveticus and Bifidobacterium longum) to standard antidepressant treatment works better than antidepressants alone for adults with major depressive disorder. The study will also learn about the safety of taking these psychobiotics with antidepressants. The main questions it aims to answer are: 1. Does adding psychobiotics lower depression symptoms more than a placebo (a look-alike capsule with no active ingredients)? 2. Is it safe and well tolerated when taken with standard antidepressant treatment? Researchers will compare psychobiotic capsules with placebo capsules to see whether psychobiotics improve depression symptoms when used together with standard antidepressants. Participants will: 1. Continue taking their prescribed antidepressant medicine. Be randomly assigned to receive either a psychobiotic capsule or a placebo capsule once daily for 6 weeks. 2. Complete depression assessments at the start of the study and again at 3 and 6 weeks. 3. Attend regular follow-up visits so researchers can monitor symptoms, side effects, and overall progress
Official title: Effect of Psychobioticsbe (Combined Lactobacillus Helveticus and Bifidobacterium Longus) With Standard Antiddepressants in Treatment of Major Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2026-01-26
Completion Date
2027-01-25
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
Lactobacillus Helveticus and bifidobacterium Longum
This study uses a specific combination of two well-studied psychobiotic strains-Lactobacillus helveticus R0052 (1.8 billion CFU) and Bifidobacterium longum R0175 (1.2 billion CFU). These strains have been selected because they may support communication between the gut and the brain and help improve mood when used alongside standard antidepressant treatment.
Placebo Capsule(s)
A placebo capsule is an orally administered capsule formulated with inert gelatin and no active ingredients. It has no psychobiotic potential and is pharmacologically inactive. The capsule is not expected to affect study outcomes or interact with oral selective serotonin reuptake inhibitors (SSRIs)
Locations (1)
Allama Iqbal Medical College, Jinnah Hospital Lahore
Lahore, Punjab Province, Pakistan