Crohn Disease
Conditions
Keywords
Fecal Microbiota Transplantation
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.
Interventions
OTHERFecal Microbiota Transplantation
FMT via colonoscopy
OTHERPlacebo
Water infusion via colonoscopy
Sponsors
Turku University Hospital
Joint Authority for Päijät-Häme Social and Health Care
Kuopio University Hospital
Helsinki University Central Hospital
Tampere University
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Safety of FMT using FinFMT-Questionnaire | 3 months, 12 months, 5 years | Unvalidated survey including 20 questions. |
| 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 |
| 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 |
| Change in inflammatory marker CRP mg/l | 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years | Median in intervention group versus plasebo group |
Countries
Finland
Contacts
Primary ContactElina Jokinen, PhD
Outcome results
None listed