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NCT04373057 · ClinicalTrials.gov registry record · Phase 1
Prebiotic Galacto-oligosaccharide and Acute GVHD
A Phase 1 study of Acute GVHD, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 2
- Study locations
NCT04373057 is a Phase 1 study of Acute GVHD that is actively recruiting participants, run by Duke University. The registered enrollment target is 128 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT04373057, a Phase 1 study of Acute GVHD, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help prevent graft-versus host disease (GVHD) after allogeneic stem cell transplant. The study has two two parts. In phase 1, the best dose of GOS will be evaluated. In phase 2, using the best dose of GOS, participants will be randomized to receive GOS or a placebo (maltodextrin, a common food additive that is not known to affect the microbiome) so that the effect of GOS can be determined.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Maltodextrin
- DIETARY_SUPPLEMENT Galacto-oligosaccharide
Study Locations (2)
Kansas
- Kansas University Medical Center - Kansas City
North Carolina
- Duke - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2021-01-22 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04373057
The ClinicalTrials.gov registry entry for NCT04373057 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute GVHD appearing as the primary indexed condition, and to 2 interventions - of which Maltodextrin is the first listed.
NCT04373057 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kansas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04373057 about?
NCT04373057 is a clinical study titled "Prebiotic Galacto-oligosaccharide and Acute GVHD". The purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help prevent graft-versus host disease (GVHD) after allogeneic stem cell transplant. The study has two tw...
What is the current status of trial NCT04373057?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2021-01-22. Estimated completion is 2028-02-01.
What conditions does trial NCT04373057 study?
This clinical trial studies the following conditions: Acute GVHD.
What interventions are being tested in trial NCT04373057?
The interventions under investigation include: Maltodextrin (DIETARY_SUPPLEMENT), Galacto-oligosaccharide (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04373057?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04373057 being conducted?
This trial has 2 study locations across Kansas, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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