Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2018-06-01
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
NCT02227342
Faecal Microbiota Transplantation in Ulcerative Colitis
NCT01896635
Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
NCT03483246
Standardized Fecal Microbiota Transplantation for Crohn's Diseases
NCT01793831
Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease
NCT01847170
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Faecal Microbiota Transplantation
Faeces acquired from a healthy donor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St Vincent's Hospital Melbourne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michael Kamm
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Kamm, MBBS
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital Melbourne
Emily Wright, MBBS
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital Melbourne
Chamara Basnayake, MBBS
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital Melbourne
Amy Hamilton, PhD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital Melbourne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Vincent's Hospital
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Amy Hamilton, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
St Vincent's Hospital
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.