An interventional study of Lactobacillus Helveticus and bifidobacterium Longum and Placebo Capsule(s) in Major Depression, sponsored by Dr Sadia yasir. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Dr Sadia yasir · Not applicable, Interventional, and Treatment
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:
Researchers will compare psychobiotic capsules with placebo capsules to see whether psychobiotics improve depression symptoms when used together with standard antidepressants.
Participants will:
Major depressive disorder (MDD) is a leading cause of disability worldwide, and many patients experience only partial improvement with antidepressant treatment alone. Increasing evidence suggests that the gut-brain axis plays an important role in the pathophysiology of depression. Psychobiotics, including Lactobacillus helveticus and Bifidobacterium longum, may improve depressive symptoms by modulating the gut microbiota, reducing inflammation, and influencing neurochemical pathways.
This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive psychobiotic therapy in adults with MDD receiving standard antidepressant treatment. Participants will continue their prescribed antidepressant medication and will be randomly assigned to receive either a psychobiotic capsule containing Lactobacillus helveticus and Bifidobacterium longum or a matching placebo once daily for 6 weeks.
Depression severity will be assessed at baseline, Week 3, and Week 6 using validated rating scales. Safety and tolerability will be evaluated through adverse event monitoring, treatment adherence, and regular follow-up visits.
The primary objective is to determine whether adjunctive psychobiotic therapy produces a greater reduction in depressive symptoms compared with placebo. Secondary objectives include evaluating safety, tolerability, treatment adherence, patient satisfaction, and quality of life. The findings will provide evidence on whether psychobiotics are an effective and safe adjunct to antidepressant therapy in adults with major depressive disorder.
Exclusion Criteria:
Severe psychiatric comorbidities (schizophrenia, bipolar disorder, co morbid substance use)
People who are recieving Psychobiotics as an adjunct to the standard treatment.
Dietary Supplement: Lactobacillus Helveticus and bifidobacterium Longum
people who will be given placebo capsules along with standard treatment
Other: Placebo Capsule(s)
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.
Also known as: psychobiotics
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)
Change in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score
The primary outcome is the difference in the mean change in the 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to Week 6 between participants receiving psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) plus standard antidepressant treatment and those receiving placebo plus standard antidepressant treatment. Higher reductions in HDRS-17 scores indicate greater improvement in depressive symptoms.
Time frame: Baseline to Week 6
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.