FMT in Inflammatory Bowel Disease

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
• Conditions: Crohn Disease; Ulcerative Colitis; Microscopic Colitis; Faecal Microbiota Transplantation
• Intervention / Treatment: Biological: Faecal Microbiota Transplantation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Recruiting
      • St Vincent's Hospital
      • Contact: Amy Hamilton, PhD

Participation Criteria

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

How is the study designed?

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	CDAI <150	8 weeks
Clinical remission in Ulcerative colitis: Total MAYO score </= 2	Total Mayo score of </=2, with all mayo sub-scores being 1 or less	8 weeks
Clinical remission in Microscopic colitis	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

• Sponsor: St Vincent's Hospital Melbourne
• 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

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: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Colitis; Colitis, Microscopic
• 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