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Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
Randomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.
Official title: Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Key Details
Gender
All
Age Range
11 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2019-09-20
Completion Date
2027-06-30
Last Updated
2025-06-12
Healthy Volunteers
No
Interventions
2'-Fucosyllactose
Human milk oligosaccharide prebiotic dietary supplement
Placebo
Dextrose
Locations (3)
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States