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NCT04598295 · ClinicalTrials.gov registry record · Phase 2
SH-DS01 on Fecal Metagenomic Stability
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT04598295: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT04598295 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04598295, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy 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.
Primary Outcome
measure of reported adverse events during the study period
Interventions
- DRUG DS-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2022-10-26 |
| Phase | Phase 2 |
What the finished NCT04598295 record still lists
NCT04598295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which DS-01 is the first listed.
NCT04598295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04598295 about?
NCT04598295 is a clinical study titled "SH-DS01 on Fecal Metagenomic Stability". This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy 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, onc...
What is the current status of trial NCT04598295?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-10-20. Estimated completion is 2022-10-26.
What interventions are being tested in trial NCT04598295?
The interventions under investigation include: DS-01 (DRUG).
Who is sponsoring clinical trial NCT04598295?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04598295's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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