Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Fecal microbiota transplantation

    Other intervention

    Stool from healthy donor administered via enema

  • Placebos

    Other intervention

    Saline with food coloring administered via enema

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: FMTExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Remission of pouchitis, defined as a pouchitis disease activity index (PDAI) score of <7, with a decreased from baseline PDAI score of 3 points

Comparison between FMT and placebo arms in remission rates

Time frame
7 weeks

Secondary outcomes

1

compliance of patients who receive FMT

Measurement of retention rate of patients who receive FMT

Time frame
7 weeks
2

compare the fecal microbiome in pouchitis patients in remission versus still active at the end of the trial.

Analysis of changes using 16S rRNA to look at changes in the bacterial profiles of patients who respond to FMT compared to those who do not

Time frame
7 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Source ClinicalTrials.gov
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