Status:

COMPLETED

Study of Sc-FOS for Pouchitis Prevention

Lead Sponsor:

Mayo Clinic

Conditions:

Pouchitis

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

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 a...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2018

    Estimated Enrollment :

    13 Patients enrolled

    Trial Details

    Trial ID

    NCT02203955

    Start Date

    August 1 2014

    End Date

    December 1 2018

    Last Update

    February 24 2020

    Active Locations (1)

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    Mayo Clinic in Rochester

    Rochester, Minnesota, United States, 55905