Fecal Microbiota Transplantation in Postoperative Crohn's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Fecal Microbiota Transplantation; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elina Jokinen, PhD; Phone Number: +3583311611; Email: elina.jokinen@pshp.fi

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Recruiting
    • Tampere University Hospital
    • Contact: Elina M Jokinen, PhD; Email: elina.jokinen@pshp.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fecal Microbiota Transplantation	Other: Fecal Microbiota Transplantation; FMT via colonoscopy
Placebo Comparator: Plasebo	Other: Placebo; Water infusion via colonoscopy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Kuopio University Hospital; Tampere University; Joint Authority for Päijät-Häme Social and Health Care

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: R20041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No