Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive Disorder
NCT ID: NCT06790823
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2022-07-15
2023-04-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic
Participants were asked to take two capsules per day for four weeks, preferably before a meal.
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.
Placebo
Participants were asked to take two placebo capsules per day for four weeks, preferably before a meal.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Substance-Induced Depressive Disorder as per DSM-5 criteria
Exclusion Criteria
* Patients who for any reason cannot comply with adequate follow-up
18 Years
70 Years
ALL
No
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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seyed hamdollah mosavat
Clinical Professor
Locations
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Shiraz University of Medical Sciences, Shiraz, Iran
Shiraz, Fars, Iran
Countries
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Other Identifiers
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IR.SUMS.REC.1400.442
Identifier Type: -
Identifier Source: org_study_id
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