Fecal Microbiota Transplantation for Pouchitis
ConditionPouchitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMcMaster University
About this trial
This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.
Eligibility criteria
Qualifiers
Patients aged 18 or over
Active pouchitis defined as PDAI of 7-18 points
Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
Disqualifiers
Participating in another clinical trial
Unable to give informed consent
Severe comorbid medical illness
Concomitant Clostridium difficile infection
Trial design
Treatments tested in this trial
- Fecal microbiota transplantation
- Placebos
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov