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Fecal Microbiota Transplantation in Postoperative Crohn's Disease

Primary Purpose

Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Placebo
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease focused on measuring Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University HospitalRecruiting
  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fecal Microbiota Transplantation

Plasebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of FMT using FinFMT-Questionnaire
Unvalidated survey including 20 questions.
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.
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.
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.
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.
Change in inflammatory marker CRP mg/l
Median in intervention group versus plasebo group
Need for hospitalization
Avarage number of days spent in hospital in intervention group vs. plasebo group
Need for treatment escalation
Number of patients needing treatment escalation from thiopurines to TNF alfa blockers in intervention group versus plasebo group
F-calpro microg/g
Median in intervention group versus plasebo group
Hb mg/l
Median in intervention group versus plasebo group

Full Information

First Posted
October 21, 2020
Last Updated
October 24, 2022
Sponsor
Tampere University Hospital
Collaborators
Turku University Hospital, Joint Authority for Päijät-Häme Social and Health Care, Kuopio University Hospital, Helsinki University Central Hospital, Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT04637438
Brief Title
Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Official Title
Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Turku University Hospital, Joint Authority for Päijät-Häme Social and Health Care, Kuopio University Hospital, Helsinki University Central Hospital, Tampere University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fecal Microbiota Transplantation
Arm Type
Active Comparator
Arm Title
Plasebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
FMT via colonoscopy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Water infusion via colonoscopy
Primary Outcome Measure Information:
Title
Change in endoscopic Rutgeerts score between first and second colonoscopy
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of FMT using FinFMT-Questionnaire
Description
Unvalidated survey including 20 questions.
Time Frame
3 months, 12 months, 5 years
Title
Clinical activity of Crohn's disease using Harwey-Bradshaw Index
Description
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.
Time Frame
6 months, 12 months, 5 years
Title
Histologic activity of Crohn's Disease using modified Global Histological Activity Score
Description
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.
Time Frame
1 years, 5 years
Title
Change of microbiota in stool samples and in intestinal biopsies
Description
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.
Time Frame
6 weeks,12 weeks, 48 weeks, 5 years
Title
Patient reported outcome
Description
IBD symptom index (IBD-SI) questionnaire. Minimum number of points 0 indicating remission, maximum number of points 15 indicating active disease or flare.
Time Frame
12 weeks, 48 weeks,years 5
Title
Change in inflammatory marker CRP mg/l
Description
Median in intervention group versus plasebo group
Time Frame
6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Title
Need for hospitalization
Description
Avarage number of days spent in hospital in intervention group vs. plasebo group
Time Frame
Through study completion, an avarage of 1 year and 5 years
Title
Need for treatment escalation
Description
Number of patients needing treatment escalation from thiopurines to TNF alfa blockers in intervention group versus plasebo group
Time Frame
Through study completion, an avarage of 1 year and 5 years
Title
F-calpro microg/g
Description
Median in intervention group versus plasebo group
Time Frame
6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Title
Hb mg/l
Description
Median in intervention group versus plasebo group
Time Frame
6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elina Jokinen, PhD
Phone
+3583311611
Email
elina.jokinen@pshp.fi
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elina M Jokinen, PhD
Email
elina.jokinen@pshp.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiota Transplantation in Postoperative Crohn's Disease

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