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Study of Sc-FOS for Pouchitis Prevention

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ClinicalTrials.gov Identifier: NCT02203955
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Laura E. Raffals, M.D, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Pouchitis Drug: Short-Chain Fructooligosaccharide Drug: Maltodextrin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Active Comparator: Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally per day for 12 months
Drug: Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally for 12 months

Placebo Comparator: Maltodextrin
4 chews (maltodextrin) daily for 12 months
Drug: Maltodextrin
4 chews (maltodextrin) daily for 12 months




Primary Outcome Measures :
  1. Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year [ Time Frame: baseline, 1 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Age 18-65 years.
  2. History of ulcerative colitis
  3. Ileostomy closure after IPAA
  4. Ability to give appropriate consent

Exclusion Criteria:

  1. Crohn's disease.
  2. Perianal disease (including abscess, fissure, or stricture)
  3. Pregnancy
  4. Lactation
  5. Concurrent treatment for IBD or pouchitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203955


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Laura Raffals, MD Mayo Clinic

Additional Information:
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Responsible Party: Laura E. Raffals, M.D, Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02203955     History of Changes
Other Study ID Numbers: 14-001220
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases