MedTrace Logo

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

NCT03847467 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2025-06-12

No results posted yet for this study

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

Interventions

DRUG

2'-Fucosyllactose

Human milk oligosaccharide prebiotic dietary supplement

OTHER

Placebo

Dextrose

Sponsors & Collaborators

  • Broad Institute of MIT and Harvard

    collaborator OTHER

  • University of Cincinnati

    collaborator OTHER

  • Connecticut Children's Medical Center

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
11 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847467 on ClinicalTrials.gov