Study of Sc-FOS for Pouchitis Prevention
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-001220
Sponsor Protocol Number: 14-001220
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion criteria:
- Age 18-65 years.
- History of ulcerative colitis
- Ileostomy closure after IPAA
- Ability to give appropriate consent
Exclusion Criteria:
- Crohn's disease.
- Perianal disease (including abscess, fissure, or stricture)
- Pregnancy
- Lactation
- Concurrent treatment for IBD or pouchitis
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Laura Raffals, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available