Crohn Disease, Faecal Microbiota Transplantation, Microscopic Colitis, Ulcerative Colitis
Conditions
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
Interventions
BIOLOGICALFaecal Microbiota Transplantation
Faeces acquired from a healthy donor
Sponsors
St Vincent's Hospital Melbourne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Contacts
Primary ContactAmy Hamilton, PhD
Outcome results
None listed