A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
University of Kansas Medical Center
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.
Description
Humans carry on the order of 100 trillion microbial cells (the microbiota),which play a major role in normal health as well as disease pathogenesis. In the gut, the microbiota interact with the intestinal epithelium and immune system to regulate inflammation and metabolism. The impact of the microbiota on GVHD and other clinical outcomes may be mediated by bacterial metabolites such as short chain fatty acid (SCFAs). In particular, the SCFA butyrate has been shown to be a preferred fuel source of human colonic epithelial cells and essential for normal differentiation of regulatory immune cells…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Plan to undergo allogeneic HCT for any cancer or non-cancer illness * Age 18-80 years * Karnofsky Performance Status \>70 Exclusion Criteria: * 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 tri…
Interventions
- Dietary SupplementGalacto-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.
- Dietary SupplementMaltodextrin
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 CenterKansas City, Kansas
- DukeDurham, North Carolina