Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

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.

NCT Number	NCT03847467
Lead Sponsor	Children's Hospital Medical Center, Cincinnati Collaborators: Broad Institute of MIT and Harvard, University of Cincinnati, Connecticut Children's Medical Center, Nationwide Children's Hospital
Conditions	Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Enrollment	128 participants
Start Date	2019-09-20
Primary Completion	2026-03-06 (estimated)
Study Completion	2026-05-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-06