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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: Recruiting Phase 1 study of Acute GVHD, sponsored by Duke University.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
GOS will be dosed as outlined using a modified 3+3 design: 0.75g x 4 days, followed by 1.5g x 4 days, followed by 2.9g for the duration of the study. If two or more subjects experience new grade 2 or 3 pre-HCT toxicities at a given dose level, that dose will be considered not tolerable and the previous dose pMTD. If two or more subjects experience new grade 2 or higher pre-HCT toxicities at the 0.75g/day dose, study may be paused to revisit the design. If one subject experiences new grade 2 or 3
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 |
What NCT04373057 shows while recruiting
NCT04373057 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT04373057's enrollment target sits among peer trials
128 453rd of 2000 higher than 1,542 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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