SH-DS01 on Fecal Metagenomic Stability
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Irritable Bowel Syndrome
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: DoublePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a randomized, double blind, 12-week comparison of the efficacy and safety of DS-01 versus placebo in a cohort of 100 men or women with IBS with constipation. 50 IBS-C or IBS-M patients will receive DS-01 (Daily Synbiotic, once daily) for 12 weeks, while 50 IBS-C or IBS-M patients will receiv...
This is a randomized, double blind, 12-week comparison of the efficacy and safety of DS-01 versus placebo in a cohort of 100 men or women with IBS with constipation. 50 IBS-C or IBS-M patients will receive DS-01 (Daily Synbiotic, once daily) for 12 weeks, while 50 IBS-C or IBS-M patients will receive the placebo (once daily). Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects will also receive extensive education on use of the synbiotic.
Tracking Information
- NCT #
- NCT04598295
- Collaborators
- Seed Health
- Investigators
- Principal Investigator: Anthony J Lembo, MD Beth Israel Deaconess Medical Center
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