Clinical trial NCT03477032: FMT in Inflammatory Bowel Disease
Official title: Faecal Transplantation in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Faecal Microbiota Transplantation
Crohn Disease
Ulcerative Colitis
Microscopic Colitis
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active inflammatory bowel disease or microscopic collitis

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


Eligibility 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

Primary outcomes:
measure: Clinical remission as defined by Crohn's disease activity index less than 150
timeFrame: 8 weeks
measure: Clinical remission in Ulcerative colitis: Total MAYO score </= 2
timeFrame: 8 weeks
measure: Clinical remission in Microscopic colitis
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Michael Kamm, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Emily Wright, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Chamara Basnayake, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital Melbourne
name: Amy Hamilton, PhD
role: PRINCIPAL_INVESTIGATOR
References: