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Study of Sc-FOS for Pouchitis Prevention

Primary Purpose

Pouchitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Short-Chain Fructooligosaccharide
Maltodextrin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pouchitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Short-Chain Fructooligosaccharide

Maltodextrin

Arm Description

4 chews (8.0 g scFOS) orally per day for 12 months

4 chews (maltodextrin) daily for 12 months

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 16, 2014
Last Updated
February 20, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02203955
Brief Title
Study of Sc-FOS for Pouchitis Prevention
Official Title
Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short-Chain Fructooligosaccharide
Arm Type
Active Comparator
Arm Description
4 chews (8.0 g scFOS) orally per day for 12 months
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
4 chews (maltodextrin) daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Short-Chain Fructooligosaccharide
Intervention Description
4 chews (8.0 g scFOS) orally for 12 months
Intervention Type
Drug
Intervention Name(s)
Maltodextrin
Intervention Description
4 chews (maltodextrin) daily for 12 months
Primary Outcome Measure Information:
Title
Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
Description
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).
Time Frame
baseline, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Raffals, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Study of Sc-FOS for Pouchitis Prevention

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