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Prebiotic Galacto-oligosaccharide and Acute GVHD
Sponsor: Duke University
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.
Official title: A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2021-01-22
Completion Date
2028-02-01
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
Galacto-oligosaccharide
GOS will be administered at determined dose levels per protocol once daily from about 30 days before transplant to about 4 weeks after transplant.
Maltodextrin
Maltodextrin will be administered at comparable dose level as GOS (in Phase II) once daily from about 30 days before transplant to about 4 weeks after transplant.
Locations (2)
Kansas University Medical Center
Kansas City, Kansas, United States
Duke
Durham, North Carolina, United States