Status:
UNKNOWN
FMT in Inflammatory Bowel Disease
Lead Sponsor:
St Vincent's Hospital Melbourne
Conditions:
Faecal Microbiota Transplantation
Crohn Disease
Eligibility:
All Genders
18-65 years
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03477032
Start Date
June 1 2018
End Date
December 31 2019
Last Update
May 29 2019
Active Locations (1)
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1
St Vincent's Hospital
Melbourne, Victoria, Australia