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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-Chain Fructooligosaccharide | Active Comparator | 4 chews (8.0 g scFOS) orally per day for 12 months |
|
| Maltodextrin | Placebo Comparator | 4 chews (maltodextrin) daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-Chain Fructooligosaccharide | Drug | 4 chews (8.0 g scFOS) orally for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year | 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). | baseline, 1 year |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Raffals, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D019449 | Pouchitis |
| ID | Term |
|---|---|
| D007079 | Ileitis |
| D004751 | Enteritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Drug | 4 chews (maltodextrin) daily for 12 months |
|
| D004066 |
| Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007077 | Ileal Diseases |