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FMT in Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03477032
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Kamm, St Vincent's Hospital Melbourne

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
Faecal Microbiota Transplantation Crohn Disease Ulcerative Colitis Microscopic Colitis Biological: Faecal Microbiota Transplantation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Faecal Transplantation in Inflammatory Bowel Disease
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement


Intervention Details:
  • Biological: Faecal Microbiota Transplantation
    Faeces acquired from a healthy donor
    Other Name: FMT


Primary Outcome Measures :
  1. Clinical remission as defined by Crohn's disease activity index less than 150 [ Time Frame: 8 weeks ]
    CDAI <150

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with active inflammatory bowel disease or microscopic collitis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477032


Contacts
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Contact: Amy Hamilton, PhD 03 9231 2211 svhm.fmt.ibd@svha.org.au

Locations
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Australia, Victoria
St Vincent's Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Amy Hamilton, PhD         
Sponsors and Collaborators
St Vincent's Hospital Melbourne
Investigators
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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

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Responsible Party: Michael Kamm, Professor, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier: NCT03477032     History of Changes
Other Study ID Numbers: St Vincent's Hospital
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Colitis, Microscopic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases