FMT in Inflammatory Bowel Disease
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Clinical remission as defined by Crohn's disease activity index less than 150 [8 weeks]
CDAI <150
- Clinical remission in Ulcerative colitis: Total MAYO score </= 2 [8 weeks]
Total Mayo score of </=2, with all mayo sub-scores being 1 or less
- Clinical remission in Microscopic colitis [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Vincent's Hospital | Melbourne | Victoria | Australia |
Sponsors and Collaborators
- St Vincent's Hospital Melbourne
Investigators
- Principal Investigator: Michael Kamm, MBBS, St Vincent's Hospital Melbourne
- Principal Investigator: Emily Wright, MBBS, St Vincent's Hospital Melbourne
- Principal Investigator: Chamara Basnayake, MBBS, St Vincent's Hospital Melbourne
- Principal Investigator: Amy Hamilton, PhD, St Vincent's Hospital Melbourne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- St Vincent's Hospital