drugset / Trial / NCT03847467
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Phase 1/2
Recruiting
116 enrolled
Children's Hospital Medical Center, Cincinnati
Broad Institute of MIT and Harvard · collabConnecticut Children's Medical Center · collabNationwide Children's Hospital · collabUniversity of Cincinnati · collab
RandomizedSequentialQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-09-20
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2'-Fucosyllactose | Other / unclassified | 1 g | — |
| Subject | 2'-Fucosyllactose | Other / unclassified | 5 g | — |
| Subject | 2'-Fucosyllactose | Other / unclassified | 10 g | — |