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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03847467
The ClinicalTrials.gov registry entry for NCT03847467 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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