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Recruiting NCT04637438

Fecal Microbiota Transplantation in Postoperative Crohn's Disease

No phase Interventional Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal Microbiota Transplantation, Placebo.
Who it may be relevant to
Registry conditions: Crohn Disease. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This pilot study aims to detect possible trends or signals suggesting efficacy of FMT on prevention of delay of POR, to determine the safety of FMT in post operative CD, and asses if a full randomised controlled trial is feasible in this setting. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.

Interventions

  • Other Fecal Microbiota Transplantation
    FMT via colonoscopy
  • Other Placebo
    Water infusion via colonoscopy

Primary outcome measures

  • Change in endoscopic Rutgeerts score between first and second colonoscopy [Time frame: 1 year]
Secondary outcome measures (10)
  • Safety of FMT using FinFMT-Questionnaire [Time frame: 3 months, 12 months, 5 years]
  • Clinical activity of Crohn's disease using Harwey-Bradshaw Index [Time frame: 6 months, 12 months, 5 years]
  • Histologic activity of Crohn's Disease using modified Global Histological Activity Score [Time frame: 1 years, 5 years]
  • Change of microbiota in stool samples and in intestinal biopsies [Time frame: 6 weeks,12 weeks, 48 weeks, 5 years]
  • Patient reported outcome [Time frame: 12 weeks, 48 weeks,years 5]
  • Change in inflammatory marker CRP mg/l [Time frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years]
  • Need for hospitalization [Time frame: Through study completion, an avarage of 1 year and 5 years]
  • Need for treatment escalation [Time frame: Through study completion, an avarage of 1 year and 5 years]
  • F-calpro microg/g [Time frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years]
  • Hb mg/l [Time frame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years]

Eligibility criteria

Inclusion criteria

  • Over 18 years
  • Able to provide written consent
  • Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection

Exclusion criteria

  • Pregnancy
  • Active infection, abscess or fistula at the time of the first colonoscopy
  • Life expectancy <1 year
  • Unable to provide written consent
  • Use on antibiotics or probiotics at the time of first colonoscopy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Finland · 2 centers
  • Tampere University Hospital — Tampere
  • Tampere University Hospital — Tampere

Identifiers

NCT: NCT04637438 · R20041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗