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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03477032 |
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Date of registration:
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19/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FMT in Inflammatory Bowel Disease
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Scientific title:
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Faecal Transplantation in Inflammatory Bowel Disease |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03477032 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Chamara Basnayake, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's Hospital Melbourne |
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Name:
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Amy Hamilton, PhD |
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Address:
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Telephone:
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03 9231 2211 |
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Email:
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svhm.fmt.ibd@svha.org.au |
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Affiliation:
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Name:
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Amy Hamilton, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Amy Hamilton, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's Hospital Melbourne |
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Name:
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Emily Wright, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's Hospital Melbourne |
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Name:
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Michael Kamm, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Vincent's Hospital Melbourne |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Faecal Microbiota Transplantation
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Crohn Disease
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Microscopic Colitis
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Ulcerative Colitis
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Intervention(s)
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Biological: Faecal Microbiota Transplantation
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Primary Outcome(s)
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Clinical remission as defined by Crohn's disease activity index less than 150
[Time Frame: 8 weeks]
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Clinical remission in Ulcerative colitis: Total MAYO score
[Time Frame: 8 weeks]
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Clinical remission in Microscopic colitis
[Time Frame: 8 weeks]
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Secondary ID(s)
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St Vincent's Hospital
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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