Last reviewed · How we verify
NCT03847467: PRIME
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Phase 1, PHASE2 trial testing 2'-Fucosyllactose in Inflammatory Bowel Diseases in 116 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 116 |
| Start date | 20 September 2019 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- 2'-Fucosyllactose — full drug profile →
- Placebo
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Children's Hospital Medical Center, Cincinnati
Who can join
Adults 11 to 25, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z -
Real world population pharmacokinetic study in children and young adults with inflammatory bowel disease discovers novel blood and stool microbial predictors of vedolizumab clearance.
Colman RJ, Mizuno T, Fukushima K, Haslam DB, et al · · 2023 · cited 21× · PMID 36314265 · DOI 10.1111/apt.17277 -
Intestinal Regulatory T Cells.
Figliuolo da Paz VR, Jamwal DR, Kiela PR. · · 2021 · cited 16× · PMID 33523448 · DOI 10.1007/978-981-15-6407-9_9 -
Microbiota-targeted strategies in IBD: therapeutic promise of 2'-fucosyllactose and beyond.
Fanous N, Talley NJ, Chaemsupaphan T, Lee E, et al · · 2025 · PMID 41179483 · DOI 10.1177/17562848251386319
Verify or expand the search:
- PubMed search for NCT03847467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 2'-Fucosyllactose
Trials testing the same drug.
- NCT06050811 — Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC) · NA · completed
- NCT06547801 — Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health · NA · completed
Other recruiting trials for Inflammatory Bowel Diseases
Currently open trials in the same condition.
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- NCT07349472 — Pentoxifylline in Patients With Ulcerative Colitis · Phase 2 · recruiting
- NCT07033208 — Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance · NA · recruiting
- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · recruiting
Other Children's Hospital Medical Center, Cincinnati trials
Trials by the same sponsor.
- NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
- NCT07077213 — 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients · recruiting
- NCT07265141 — An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics · NA · not yet recruiting
- NCT07217444 — Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation · NA · recruiting
- NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03847467 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
- Last refreshed: 12 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03847467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing