At a glance
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A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
In Brief
A Phase 2 clinical trial evaluating Galacto-oligosaccharide and Maltodextrin for Acute GVHD. Currently recruiting, targeting 128 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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 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.