NCT06790823

Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder

Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the potential of probiotics as a therapeutic intervention for Substance-Induced Depressive Disorder (SIDD). The primary question the study aims to answer is: Can a four-week course of probiotics improve depressive symptoms and alter immune markers in patients diagnosed with SIDD, compared to a placebo? The study uses a double-blind, placebo-controlled, randomized clinical trial design with 40 participants to explore this question by measuring clinical outcomes using BDI and HAM-A and immunological markers.

Conditions

• Depressive Disorder
• Depressive Disorder, Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	The probiotic supplement (Moodamin capsuls)	The probiotic supplement (Moodamin capsuls) provided from Amin pharmacytical company, Iran, was freeze-dried containing Lactobacillus helveticus and Bifidobacterium Longum bacteria at a dose of 2.682 × CFU and 0.318 × CFU each capsule, respectively.Excipients include xylitol, maltodextrin, plum flavor, and malic acid.
DRUG	Placebo	The probiotic supplement (Moodamin capsuls) provided from Amin pharmacytical company, Iran, was freeze-dried containing Lactobacillus helveticus and Bifidobacterium Longum bacteria at a dose of 2.682 × CFU and 0.318 × CFU each capsule, respectively. Excipients include xylitol, maltodextrin, plum flavor, and malic acid. A placebo product used for the control group was made up of excipients only.

Timeline

• Start date: 2022-07-15
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2025-01-24
• Last updated: 2025-06-13

Locations

1 site across 1 country: Iran