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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 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04598295
The ClinicalTrials.gov registry entry for NCT04598295 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DS-01 is the first listed.
NCT04598295 reports 0 study locations.
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.
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