Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Children's Hospital Medical Center, Cincinnati
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
- Age range
- 11–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 11 - 25 4. Diagnosed with Crohns Disease or Ulcerative Colitis 5. Disease is in remission * Adult CD (age 18-25): CDAI score \< 150 * Pediatric CD (age 11-17): wPCDAI \< 12.5 * Adult UC (age 18-25): Modified Mayo sub-scores: stool frequency sub-score=0, rectal bleeding sub-score=0 * Pediatric UC (age 11-17): PUCAI score \< 10 6. Not receiving corticosteroids 7. Receiving a stable…
Interventions
- Drug2'-Fucosyllactose
Human milk oligosaccharide prebiotic dietary supplement
- OtherPlacebo
Dextrose
Locations (3)
- Connecticut Children's Medical CenterHartford, Connecticut
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Nationwide Children's HospitalColumbus, Ohio