Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fecal Microbiota Transplantation<br> | Other: Fecal Microbiota Transplantation<br>* FMT via colonoscopy<br>|
| Placebo Comparator: Plasebo<br> | Other: Placebo<br>* Water infusion via colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endoscopic Rutgeerts score between first and second colonoscopy | Rutgeerts endoscopic score ranges from i0 indicating remission to i4 indicating severe post-operative relapse. Cut off value > i1 will be used to compare number on patients in intervention group and in placebo group. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of FMT using FinFMT-Questionnaire | Unvalidated survey including 20 questions. | 3 months, 12 months, 5 years | 
| Clinical activity of Crohn's disease using Harwey-Bradshaw Index | Scores of less that 5 indicate that the patient's Crohn's disease is in remission while scores higher than 16 indicate severe disease activity. Median scores will be compared between intervention group and placebo group. | 6 months, 12 months, 5 years | 
| Histologic activity of Crohn's Disease using modified Global Histological Activity Score | The GHAS consists of eight items assessing acute and chronic inflammatory changes, epithelial damage and the extent of inflammation (i.e. the proportion of biopsy specimens affected). Each of the eight items is scored, with the totals subsequently added together. Maximum number 14 indicates histological activity. The median GHAS score will be compared between intervention group and placebo group. | 1 years, 5 years | 
| Change of microbiota in stool samples and in intestinal biopsies | The relative abundances of taxonomic units in cases versus controls and different time points will be compared at the level of phylum, class, genus, species and OTU. Alpha diversity measures will be determined from the original unfiltered dataset by counting observed taxa (OTU richness) and by Chao1, ACE, Shannon, Simpson and Fisher indices; diversity will be compared between time points.cases and controls. Beta diversity will be assessed by examining the results of principle component analysis using multiple distance methods, if appreciable difference between cases and controls or time points will be noted, formal testing of clustering will be performed. To simplify complex bacteriome profiles, we will also sort each sample into enterotypes based on the leading components of their bacteriomes; the enterotypes will be tested as a predictor of the case-control or disease status of cases. | 6 weeks,12 weeks, 48 weeks, 5 years | 
| Patient reported outcome | IBD symptom index (IBD-SI) questionnaire. Minimum number of points 0 indicating remission, maximum number of points 15 indicating active disease or flare. | 12 weeks, 48 weeks,years 5 | 
| Change in inflammatory marker CRP mg/l | Median in intervention group versus plasebo group | 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years | 
| Need for hospitalization | Avarage number of days spent in hospital in intervention group vs. plasebo group | Through study completion, an avarage of 1 year and 5 years | 
| Need for treatment escalation | Number of patients needing treatment escalation from thiopurines to TNF alfa blockers in intervention group versus plasebo group | Through study completion, an avarage of 1 year and 5 years | 
| F-calpro microg/g | Median in intervention group versus plasebo group | 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years | 
| Hb mg/l | Median in intervention group versus plasebo group | 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota Transplantation