Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS
NCT06346847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384
Last updated 2026-03-23
Summary
The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of postbiotic on anxiety, low mood and stress of the participants, as well as its safety and tolerability.
The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase).
Conditions
- Diarrhea-Predominant Irritable Bowel Syndrome
Interventions
- DIETARY_SUPPLEMENT
-
Postbiotic
1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks
- DIETARY_SUPPLEMENT
-
Placebo
1 capsule a day, 15 minutes before breakfast with a glass of water for 12 weeks
Sponsors & Collaborators
-
Vedic Lifesciences Pvt. Ltd.
collaborator INDUSTRY -
A-Mansia Biotech S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-18
- Primary Completion
- 2025-05-29
- Completion
- 2025-07-13
Countries
- India
Study Locations
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