Trial Details

None
Basic Information
Clinical ID c2730
Identifier ACTRN12618001590257
Trial Title Gut Microbiome Transfer for the Treatment of Crohn Disease
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Crohn's Disease;Inflammatory Bowel Disease; Crohn's Disease Inflammatory Bowel Disease;Oral and Gastrointestinal - Crohn's disease;Oral and Gastrointestinal - Inflammatory bowel disease
Interventions Gut Microbiome Transfer (GMT) capsules - a 650 ul aliquot of pooled bacteria (resuspended in 0.9% saline solution containing 15% glycerol) that was isolated from the stool of 4 healthy, clinically screened donors will be double encapsulated into size 0 and size 00 DRcpasTM capsules. Placebo capsules - a 650 ul aliquot of 0.9% saline solution containing 15% glycerol will be double encapsulated into size 0 and size 00 DRcpasTM capsules. Participants will be blindly randomized to receive either the intervention (GMT capsules) or the placebo (saline capsules). These capsules will be given to participants to swallow with water on three occasions under direct supervision by research staff Dose 1 - baseline: 16 capsules Dose 2 - week 2: 14 capsules Dose 3 - week 4: 14 capsules
Participant Information
Sponsor Associate Professor Justin O'Sullivan
City -
Country/Region New Zealand
Enrollment Criteria
Sex Requirement MALE
Age Requirement ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -