Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Other: Fecal Microbiota Transplantation; Other: Placebo

• Registration Number: NCT04637438
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Study Start: 2021-05-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27
• Primary Completion: 2023-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation	Fecal Microbiota Transplantation	-
Plasebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in endoscopic Rutgeerts score between first and second colonoscopy	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Need for hospitalization	Through study completion, an avarage of 1 year and 5 years	Avarage number of days spent in hospital in intervention group vs. plasebo group
Clinical activity of Crohn's disease using Harwey-Bradshaw Index	6 months, 12 months, 5 years	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.
Histologic activity of Crohn's Disease using modified Global Histological Activity Score	1 years, 5 years	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.
Change in inflammatory marker CRP mg/l	6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years	Median in intervention group versus plasebo group
Need for treatment escalation	Through study completion, an avarage of 1 year and 5 years	Number of patients needing treatment escalation from thiopurines to TNF alfa blockers in intervention group versus plasebo group
F-calpro microg/g	6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years	Median in intervention group versus plasebo group
Hb mg/l	6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years	Median in intervention group versus plasebo group
Safety of FMT using FinFMT-Questionnaire	3 months, 12 months, 5 years	Unvalidated survey including 20 questions.
Change of microbiota in stool samples and in intestinal biopsies	6 weeks,12 weeks, 48 weeks, 5 years	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.
Patient reported outcome	12 weeks, 48 weeks,years 5	IBD symptom index (IBD-SI) questionnaire. Minimum number of points 0 indicating remission, maximum number of points 15 indicating active disease or flare.

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland