- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477032
FMT in Inflammatory Bowel Disease
May 26, 2019 updated by: Michael Kamm, St Vincent's Hospital Melbourne
Faecal Transplantation in Inflammatory Bowel Disease
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy Hamilton, PhD
- Phone Number: 03 9231 2211
- Email: svhm.fmt.ibd@svha.org.au
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia
- Recruiting
- St Vincent's hospital
-
Contact:
- Amy Hamilton, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with active inflammatory bowel disease or microscopic collitis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical remission as defined by Crohn's disease activity index less than 150
Time Frame: 8 weeks
|
CDAI <150
|
8 weeks
|
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
|
8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (ACTUAL)
March 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 29, 2019
Last Update Submitted That Met QC Criteria
May 26, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- St Vincent's Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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