Prebiotic Galacto-oligosaccharide and Acute GVHD
A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
Duke University
128 participants
Jan 22, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Plan to undergo allogeneic HCT for any cancer or non-cancer illness
- Age 18-80 years
- Karnofsky Performance Status >70
Exclusion Criteria6
- Pregnant/lactating
- Malabsorption syndrome, short bowel or chologenic diarrhea
- At time of enrollment, Grade 2 or higher GI symptoms per NCI-CTCAE
- Active treatment with other prebiotics, probiotics, or herbal supplementation (ok if stops before enrollment)
- Active treatment with antibiotics (with the exception of prophylactic antibiotics)
- Concurrent enrollment on the Duke HCT Home Transplant study or another clinical trial targeting GVHD; patients who are enrolled in observational or non-pharmacologic intervention trials (for example, the Duke HCT Research-POP Pre and Peri-HCT Optimization Program aka "R-POP") or pharmacologic or cellular therapy trials with other targets (for example, NK DLI) are NOT excluded
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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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04373057