RecruitingPhase 1Phase 2NCT03847467

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

116 participants

Start Date

Sep 20, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 11 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a dietary supplement called 2'-fucosyllactose (2'-FL) — a sugar naturally found in human breast milk — can help maintain remission and support gut health in young patients with Crohn's disease or ulcerative colitis who are already on a biologic medication. **You may be eligible if...** - You are between 11 and 25 years old - You have been diagnosed with Crohn's disease or ulcerative colitis - Your disease is currently in remission (well-controlled) - You are on a stable dose of an anti-TNF biologic medication (adalimumab or infliximab) for at least 12 weeks - You are not currently taking corticosteroids (steroid medications) **You may NOT be eligible if...** - Your disease is currently active (not in remission) - You are taking corticosteroids - You are not currently on one of the specified biologic medications - Your disease activity score does not meet the remission criteria for your age and disease type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG2'-Fucosyllactose

Human milk oligosaccharide prebiotic dietary supplement

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT03847467


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