Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03847467 · ClinicalTrials.gov registry record · Phase 1
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
A Phase 1 study of Ulcerative Colitis and Crohn Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
- 3
- Study locations
NCT03847467: Recruiting Phase 1 study of Ulcerative Colitis and Crohn Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03847467 is a Phase 1 study of Ulcerative Colitis and Crohn Disease that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 116 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03847467, a Phase 1 study of Ulcerative Colitis and Crohn Disease, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Measured by the Gastrointestinal Symptom Rating Scale (GSRS). The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire for patients with GI symptoms. Patients are asked to numerically score their subjective symptoms on a scale of 1-7 (1=no discomfort up to 7=severe discomfort). The sum of the scores for all 15 items is regarded as the GSRS total score
Conditions Studied
Interventions
- OTHER Placebo
- DRUG 2'-Fucosyllactose
Study Locations (3)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What NCT03847467 shows while recruiting
NCT03847467 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03847467 reports a single indexed study location in Ohio, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03847467 about?
NCT03847467 is a clinical study titled "Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy". 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 mann...
What is the current status of trial NCT03847467?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2019-09-20. Estimated completion is 2027-06-30.
What conditions does trial NCT03847467 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT03847467?
The interventions under investigation include: Placebo (OTHER), 2'-Fucosyllactose (DRUG).
Who is sponsoring clinical trial NCT03847467?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03847467 being conducted?
This trial has 3 study locations across Connecticut, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03847467's enrollment target sits among peer trials
116 63rd of 122 higher than 60 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
RECRUITING · Phase 1
-
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
RECRUITING · Phase 1
-
CP101 for the Treatment of Ulcerative Colitis
ACTIVE NOT RECRUITING · Phase 1
-
Angiographic Delivery of AD-MSC for Ulcerative Colitis
ACTIVE NOT RECRUITING · Phase 1
-
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
COMPLETED · Phase 1
-
Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03014687 · 116 participants · Phase 4
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
- NCT03214562 · 116 participants · Phase 1
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
- NCT04222413 · 116 participants · Phase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
- NCT04372615 · 116 participants · Phase 2
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI