2'-Fucosyllactose for Crohn's Disease Remission
Dosing and Pilot Efficacy of 2'-Fucosyllactose in Inflammatory Bowel Disease
['FUNDING_R01'] · CINCINNATI CHILDRENS HOSP MED CTR · NIH-11141180
This project is exploring if a dietary supplement called 2'-fucosyllactose can help children and young adults with Crohn's disease stay in remission.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | CINCINNATI CHILDRENS HOSP MED CTR (nih funded) |
| Locations | 1 site (CINCINNATI, UNITED STATES) |
| Trial ID | NIH-11141180 on ClinicalTrials.gov |
What this research studies
Crohn's disease can be unpredictable, and changes in gut bacteria might play a role in relapses. This project is looking at a special carbohydrate called 2'-fucosyllactose (2'-FL), found in human milk, as a "prebiotic" to help restore healthy gut bacteria. We want to find out if 2'-FL is safe and well-tolerated, and if it can increase beneficial bacteria like Bifidobacterium and a helpful substance called butyrate in your gut. The project involves a randomized, placebo-controlled study where participants will take either 1g or 5g of 2'-FL or a placebo daily, and we will check for safety, how well it's tolerated, and changes in gut bacteria and inflammation markers.
Who could benefit from this research
Good fit: Ideal candidates are pediatric and young adult patients with Crohn's disease who are currently in stable remission and receiving infliximab or adalimumab anti-TNF therapy.
Not a fit: Patients not in remission, those not on anti-TNF therapy, or adults outside the pediatric/young adult age range may not be suitable for this specific project.
Why it matters
Potential benefit: If successful, this could offer a new, safe dietary supplement to help patients with Crohn's disease stay in remission and prevent relapses.
How similar studies have performed: This project represents the first studies of 2'-fucosyllactose for maintaining remission in Crohn's disease, making it a novel approach.
Where this research is happening
CINCINNATI, UNITED STATES
- CINCINNATI CHILDRENS HOSP MED CTR — CINCINNATI, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: DENSON, LEE ARMISTEAD — CINCINNATI CHILDRENS HOSP MED CTR
- Study coordinator: DENSON, LEE ARMISTEAD
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.