NCT03847467

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 11 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	2'-Fucosyllactose	Human milk oligosaccharide prebiotic dietary supplement
OTHER	Placebo	Dextrose

Timeline

• Start date: 2019-09-20
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2019-02-20
• Last updated: 2025-06-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study