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NCT04263597 · ClinicalTrials.gov registry record · Phase 1
Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT04263597: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04263597 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04263597, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
High dose chemotherapy and radiation used as preparative regimens in patients undergoing an allogeneic hematopoietic stem cell transplant (HSCT) disrupts intestinal homeostasis by damaging the intestinal epithelium and altering the intestinal microbiome. The investigators hypothesize that 2'-fucosyllactose (2FL) supplementation will be safe and tolerable and result in an increase in the relative abundance of intestinal Bifidobacteria. The investigators also hypothesize that 2FL supplementation will lead to reduction of Firmicutes and/or Proteobacteria, and improved intestinal homeostasis at day+30 as measured by lower pro-inflammatory cytokines, reduced levels of T-cell activation, lower markers of intestinal injury (fecal human DNA and plasma reg-3-alpha), increased fecal butyrate levels and ultimately lower incidence of acute GVHD and BSI at day+100. Phase II: The investigators hypothesize that 2FL supplementation will be safe and tolerable and result in an increase in the relative abundance of fecal short chain fatty acids such as butyrate, acetate and propionate at day+7 compared to baseline values.
Primary Outcome
Patients with a bloodstream infection occurring anytime between first day of 2-FL dosing until day+100 after transplant were collected. Typically 2FL was started with start of chemotherapy which was usually up to 22 days before transplant
Interventions
- DRUG 2'-fucosyllactose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2025-05-23 |
| Phase | Phase 1 |
What the finished NCT04263597 record still lists
NCT04263597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 1 intervention - of which 2'-fucosyllactose is the first listed.
NCT04263597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04263597 about?
NCT04263597 is a clinical study titled "Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients". High dose chemotherapy and radiation used as preparative regimens in patients undergoing an allogeneic hematopoietic stem cell transplant (HSCT) disrupts intestinal homeostasis by damaging the intestinal epithelium and altering the intestinal microbiome. The investigators hypothesize that 2'-fucosyl...
What is the current status of trial NCT04263597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2020-08-26. Estimated completion is 2025-05-23.
What interventions are being tested in trial NCT04263597?
The interventions under investigation include: 2'-fucosyllactose (DRUG).
Who is sponsoring clinical trial NCT04263597?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04263597's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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