FMT in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Faecal Transplantation in Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477032
• Other study ID #: St Vincent's Hospital
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: St Vincent's Hospital Melbourne
• Contact: Amy Hamilton, PhD
• Phone: 03 9231 2211
• Email: svhm.fmt.ibd[@]svha.org.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Colitis, Ulcerative
• Crohn Disease
• Faecal Microbiota Transplantation
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Microscopic Colitis
• Ulcerative Colitis

Intervention

Biological:
• Faecal Microbiota Transplantation
Faeces acquired from a healthy donor

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
St Vincent's Hospital Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission as defined by Crohn's disease activity index less than 150	CDAI <150	8 weeks
Primary	Clinical remission in Ulcerative colitis: Total MAYO score </= 2	Total Mayo score of	8 weeks
Primary	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