Gut Microbiome Transfer for the Treatment of Crohn’s Disease

INTERVENTION: 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 CONDITION: Crohn's Disease Inflammatory Bowel Disease PRIMARY OUTCOME: Change in severity of intestinal inflammation as assessed by endoscopic index score SECONDARY OUTCOME: Change in Crohn's disease symptom severity as assessed by Harvey Bradshaw Index (HBI) score Change in health‐related quality of life as assessed by the short inflammatory bowel disease questionnaire (SIBDQ) Explore any changes to body mass index (BMI) as assessed via anthropomorphic measurements Explore any changes to the gut microbiome (diversity, composition and function) as assessed by metagenomic, metatranscriptomic, and metabolomic technologies INCLUSION CRITERIA: Patients ‐ male ‐ 20‐50 years old ‐ mild to moderate Crohn's disease (HBI 5‐16) Donors ‐ male ‐ 20‐50 years old ‐ healthy ‐ BMI 18.5 ‐ 24.9 kg/m2