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Status unknownNCT03477032Updated May 29, 2019

FMT in Inflammatory Bowel Disease

An observational study in Faecal Microbiota Transplantation, Crohn Disease and Ulcerative Colitis, sponsored by St Vincent's Hospital Melbourne. Status unknown at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by St Vincent's Hospital Melbourne · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Faecal Microbiota Transplantation
  • Crohn Disease
  • Ulcerative Colitis
  • Microscopic Colitis
03

In context

Crohn Disease

1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.

This study's planned enrollment of 50 is below the median of 185 across 645 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

St Vincent's Hospital Melbourne is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with active inflammatory bowel disease or microscopic collitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • BiologicalFaecal Microbiota Transplantation

    Faeces acquired from a healthy donor

    Also known as: FMT

06

What researchers measure

Primary outcomes

  1. Clinical remission as defined by Crohn's disease activity index less than 150

    CDAI \<150

    Time frame: 8 weeks

  2. Clinical remission in Ulcerative colitis: Total MAYO score </= 2

    Total Mayo score of \</=2, with all mayo sub-scores being 1 or less

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • St Vincent's Hospital
    Melbourne, Victoria, Australia
    Recruiting
    • Amy Hamilton, PhD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2018 (actual). Primary completion is estimated for Dec 2019, 18 months after the start.

Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 18 months is below that.

Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 26, 2018
StartActual
Jun 1, 2018
Primary completionEst.
Dec 31, 2019
CompletionEst.
Dec 31, 2019
Last update
May 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477032
Lead sponsor
St Vincent's Hospital Melbourne
Responsible party
Michael Kamm (Professor, St Vincent's Hospital Melbourne) — Principal investigator
First posted
Mar 26, 2018
Start date
Jun 1, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
May 29, 2019

Study contacts

Amy Hamilton, PhD
Contact
svhm.fmt.ibd@svha.org.au
03 9231 2211
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
Amy Hamilton, PhD
principal investigator · St Vincent's Hospital Melbourne

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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