Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03477032
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03477032
Study Brief:
Protocol Section:
NCT03477032