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NCT02203955 · ClinicalTrials.gov registry record · Phase 1
Study of Sc-FOS for Pouchitis Prevention
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02203955: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02203955 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02203955, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.
Primary Outcome
In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (\<7 points).
Interventions
- DRUG Maltodextrin
- DRUG Short-Chain Fructooligosaccharide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
What the finished NCT02203955 record still lists
NCT02203955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Maltodextrin is the first listed.
NCT02203955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02203955 about?
NCT02203955 is a clinical study titled "Study of Sc-FOS for Pouchitis Prevention". The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites a...
What is the current status of trial NCT02203955?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-08. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02203955?
The interventions under investigation include: Maltodextrin (DRUG), Short-Chain Fructooligosaccharide (DRUG).
Who is sponsoring clinical trial NCT02203955?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02203955's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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