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NCT03721107 · ClinicalTrials.gov registry record · Phase 2
A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome
A Phase 2 study, sponsored by 4D pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 366
- Enrollment target
NCT03721107: Completed Phase 2 study, sponsored by 4D pharma.
NCT03721107 is a Phase 2 study that has completed, run by 4D pharma. The registered enrollment target is 366 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (175% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03721107, a Phase 2 study, has completed, sponsored by 4D pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 366 participants
- Enrollment target
Study Summary
A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).
Primary Outcome
Overall responder was a participant who has at least 7 evaluable weeks of data and has reported an improvement in their weekly symptoms (abdominal pain intensity \[API\] and stool frequency \[SF\] or consistency \[SC\]) for greater than or equal to (\>=) 50 percent (%) of the treatment period. Improvement for abdominal pain intensity was defined as decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline for Cohort C and Cohort D, for s
Interventions
- OTHER Placebo
- BIOLOGICAL Blautix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2020-05-13 |
| Phase | Phase 2 |
What the finished NCT03721107 record still lists
NCT03721107 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (175% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03721107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03721107 about?
NCT03721107 is a clinical study titled "A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome". A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).
What is the current status of trial NCT03721107?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 366 participants. The study started on 2018-10-11. Estimated completion is 2020-05-13.
What interventions are being tested in trial NCT03721107?
The interventions under investigation include: Placebo (OTHER), Blautix (BIOLOGICAL).
Who is sponsoring clinical trial NCT03721107?
This trial is sponsored by 4D pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03721107's enrollment target sits among peer trials
366 121st of 2000 higher than 1,880 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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