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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03477032




Registration number
NCT03477032
Ethics application status
Date submitted
19/03/2018
Date registered
26/03/2018
Date last updated
29/05/2019

Titles & IDs
Public title
FMT in Inflammatory Bowel Disease
Scientific title
Faecal Transplantation in Inflammatory Bowel Disease
Secondary ID [1] 0 0
St Vincent's Hospital
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal Microbiota Transplantation 0 0
Crohn Disease 0 0
Ulcerative Colitis 0 0
Microscopic Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Faecal Microbiota Transplantation

Other interventions: Faecal Microbiota Transplantation
Faeces acquired from a healthy donor
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical remission as defined by Crohn's disease activity index less than 150
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Clinical remission in Ulcerative colitis: Total MAYO score </= 2
Timepoint [2] 0 0
8 weeks
Primary outcome [3] 0 0
Clinical remission in Microscopic colitis
Timepoint [3] 0 0
8 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT03477032
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Kamm, MBBS
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Hamilton, PhD
Address 0 0
Country 0 0
Phone 0 0
03 9231 2211
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03477032