Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637438
• Other study ID #: R20041
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: December 2027

Study information

• Verified date: October 2022
• Source: Tampere University Hospital
• Contact: Elina Jokinen, PhD
• Phone: +3583311611
• Email: elina.jokinen[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2027
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere
Finland	Tampere University Hospital	Tampere

Sponsors (6)

Lead Sponsor	Collaborator
Tampere University Hospital	Helsinki University Central Hospital, Joint Authority for Päijät-Häme Social and Health Care, Kuopio University Hospital, Tampere University, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of FMT using FinFMT-Questionnaire	Unvalidated survey including 20 questions.	3 months, 12 months, 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in inflammatory marker CRP mg/l	Median in intervention group versus plasebo group	6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Secondary	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
Secondary	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
Secondary	F-calpro microg/g	Median in intervention group versus plasebo group	6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Secondary	Hb mg/l	Median in intervention group versus plasebo group	6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years