Fecal Microbiota Transplantation in Postoperative Crohn's Disease
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedStudy Start
First participant enrolled
May 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedOctober 27, 2022
October 1, 2022
2.5 years
October 21, 2020
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Safety of FMT using FinFMT-Questionnaire
3 months, 12 months, 5 years
Clinical activity of Crohn's disease using Harwey-Bradshaw Index
6 months, 12 months, 5 years
Histologic activity of Crohn's Disease using modified Global Histological Activity Score
1 years, 5 years
Change of microbiota in stool samples and in intestinal biopsies
6 weeks,12 weeks, 48 weeks, 5 years
Patient reported outcome
12 weeks, 48 weeks,years 5
- +5 more secondary outcomes
Study Arms (2)
Fecal Microbiota Transplantation
ACTIVE COMPARATORPlasebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Over 18 years
- Able to provide written consent
- Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Turku University Hospitalcollaborator
- Joint Authority for Päijät-Häme Social and Health Carecollaborator
- Kuopio University Hospitalcollaborator
- Helsinki University Central Hospitalcollaborator
- Tampere Universitycollaborator
Study Sites (2)
Tampere University Hospital
Tampere, 33521, Finland
Tampere University Hospital
Tampere, 33521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of Medical Science
Study Record Dates
First Submitted
October 21, 2020
First Posted
November 19, 2020
Study Start
May 18, 2021
Primary Completion
December 1, 2023
Study Completion (Estimated)
December 1, 2027
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share