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Study identifier: NCT03847467 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Inflammatory Bowel Diseases · Crohn Disease · Ulcerative Colitis  ·  Sponsor: Children's Hospital Medical Center, Cincinnati

PhasePhase 1/Phase 2
Planned participants116
Who can joinAll sexes, 11 Years to 25 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ramona Bezold, BSN  ·  1-(513)-636-1412  ·  Ramona.Bezold@cchmc.org

Always discuss trial participation with your own doctor first.

Locations (3)

Connecticut Children's Medical CenterHartford, Connecticut, United StatesRecruiting
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio, United StatesRecruiting
Nationwide Children's HospitalColumbus, Ohio, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT03847467