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RECRUITING
NCT03847467
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

DRUG

2'-Fucosyllactose

Human milk oligosaccharide prebiotic dietary supplement

OTHER

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