NCT03477032UnknownNot Applicable
Faecal Transplantation in Inflammatory Bowel Disease
St Vincent's Hospital Melbourne1 site in 1 country50 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical remission as defined by Crohn's disease activity index less than 150
Study Overview
Brief Summary
This is a prospective observational cohort study, over 52 weeks, evaluating the the use of faecal microbiota transplantation amongst patients with Inflammatory Bowel Disease and Microscopic Colitis
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with inflammatory bowel disease (Crohn's disease or Ulcerative colitis) or Microscopic Colitis proven on the basis of radiology, endoscopy or histology.
- •Patients with clinically and endoscopically active, Crohn's Disease, Ulcerative Colitis or Microscopic Colitis
- •Patient must have attempted reasonable medical therapies to control their disease without sufficient response.
- •All patients have to be capable of attending appointments, as well completing surveys and diagnostic tests for the duration of study follow up
- •The patient must be able to identify a likely stool donor
Exclusion Criteria
- •Patients with an enteropathy or colitis which cannot definitively be diagnosed as Ulcerative Colitis, Crohn's disease or Microscopic colitis
- •Patients with concurrent Clostridium difficile infection
- •Women who are pregnant or intending to become pregnant in the near future (less than 6 months).
- •Neutrophils less than 1.0 x 109/L
- •Albumin less than 20g/L
- •Active gastrointestinal infection as identified by testing
- •A patient on steroids (prednisolone, budesonide) at a dose that cannot be safely tapered to zero within 6 weeks of initial FMT, due to the risk of adrenal insufficiency
- •Short gut syndrome and/or small intestine less than 1.5m in length as measured intra-operatively
- •Perforation or active internal fistulising disease or enterocutaneous fistulae.
- •Any patient that the clinicians feel is incapable of participating in the safe use of FMT.
- •Current use of antibiotics for any condition
Outcomes
Primary Outcomes
Clinical remission as defined by Crohn's disease activity index less than 150
Time Frame: 8 weeks
CDAI \<150
Clinical remission in Microscopic colitis
Time Frame: 8 weeks
Mean of \<3 stools/day, including a mean of \<1 watery stool/day over 1 week and if steroid dependent, the ability to cease steroids without increasing symptoms over baseline disease activity assessment.
Clinical remission in Ulcerative colitis: Total MAYO score </= 2
Time Frame: 8 weeks
Total Mayo score of \</=2, with all mayo sub-scores being 1 or less
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Kamm
Professor
St Vincent's Hospital Melbourne
Study Sites (1)
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