FMT in Inflammatory Bowel Disease

NCT03477032 | Unknown DMC

• 1 other identifier: St Vincent's Hospital
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Faecal Microbiota Transplantation; Crohn Disease; Ulcerative Colitis; Microscopic Colitis

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Faecal Microbiota Transplantation BIOLOGICAL

Faeces acquired from a healthy donor

Also known as: FMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active inflammatory bowel disease or microscopic collitis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead

Study Sites (1)

St Vincent's Hospital

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Colitis, Microscopic

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Hamilton, PhD

CONTACT

03 9231 2211; svhm.fmt.ibd@svha.org.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)