Faecal Microbiota TransplantationNCT03477032
FMT in Inflammatory Bowel Disease
An observational study of Faecal Microbiota Transplantation and Crohn Disease, run by St Vincent's Hospital Melbourne at 1 site in Australia.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Faecal Microbiota Transplantation, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Faecal Microbiota Transplantation
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active inflammatory bowel disease or microscopic collitis
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
St Vincent's Hospital
Melbourne, Victoria
Amy Hamilton, PhD
About this study
Official title: 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
- Being tested
- Faecal Microbiota Transplantation
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Colitis, Microscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal Microbiota TransplantationBiological
Also called FMT
Faeces acquired from a healthy donor
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission as defined by Crohn's disease activity index less than 150
CDAI <150
Measured: 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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal Microbiota TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kamm, St Vincent's Hospital Melbourne
- Investigators
- Michael Kamm, MBBS, Principal investigator, St Vincent's Hospital MelbourneEmily Wright, MBBS, Principal investigator, St Vincent's Hospital MelbourneChamara Basnayake, MBBS, Principal investigator, St Vincent's Hospital MelbourneAmy Hamilton, PhD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477032
- Sponsor's protocol ID
- St Vincent's Hospital
- Status last verified
- May 2019
- First submitted
- 19 Mar 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Transplantation in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03477032
- Acronym / sponsor ID
- St Vincent's Hospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active inflammatory bowel disease or microscopic collitis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faecal Microbiota TransplantationAlso: FMTFaeces acquired from a healthy donor | Biological | – |
Primary outcome
Clinical remission as defined by Crohn's disease activity index less than 150
Time frame: 8 weeks
CDAI <150
Clinical remission in Ulcerative colitis: Total MAYO score </= 2
Time frame: 8 weeks
Total Mayo score of </=2, with all mayo sub-scores being 1 or less
Clinical remission in Microscopic colitis
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No
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The Finnish Faecal Microbiota Transplantation Study (FINFMT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kamm, MBBS principal investigator
St Vincent's Hospital Melbourne
Emily Wright, MBBS principal investigator
St Vincent's Hospital Melbourne
Chamara Basnayake, MBBS principal investigator
St Vincent's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Faecal Microbiota Transplantation and Crohn Disease, run by St Vincent's Hospital Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Hamilton, PhD (03 9231 2211, svhm.fmt.ibd@svha.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission as defined by Crohn's disease activity index less than 150 (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019; AzTrials last refreshed its copy on 31 Oct 2026.