Status:

COMPLETED

Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa

Lead Sponsor:

Medical University of Graz

Conditions:

Colitis, Ulcerative

Eligibility:

All Genders

18+ years

Brief Summary

Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavou...

Detailed Description

The Investigators suggest that certain alterations in the intestinal microbiota are at least in part responsible for the inability of some patients to response to steroid therapy and probably also for...

Eligibility Criteria

Inclusion

  • Active ulcerative colitis with a Lichtiger score ≥4
  • Patient scheduled for steroid therapy with systemic steroids (prednisolone or methylprednisolone) at standard dosing and patients who started steroid therapy not longer than 48 hours prior to the study inclusion.
  • Written informed consent
  • Established or suspected diagnosis of ulcerative colitis or indeterminate colitis

Exclusion

  • No follow up possible
  • Bacterial intestinal infections (C. difficile, Salmonella, EHEC, Campylobacter, Shigella, Yersinia), parasitic or viral infection causing acute infectious diarrhea at baseline.
  • Diagnosis of Crohn´s disease
  • Planned initiation or discontinuation of probiotic therapy between baseline and follow up visit

Key Trial Info

Start Date :

March 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2021

Estimated Enrollment :

114 Patients enrolled

Trial Details

Trial ID

NCT03460847

Start Date

March 1 2018

End Date

March 1 2021

Last Update

September 8 2021

Active Locations (1)

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LKH Graz

Graz, Styria, Austria, 8036