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 two parts. In phase 1,
| Condition(s) | Acute GVHD |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 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 pharma |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | University of Kansas Medical Center |
| Locations | Kansas City, Kansas, United States; Durham, North Carolina, United States |
| Start date | 2021-01-22 |
| NCT ID | NCT04373057 |
| Official listing | https://clinicaltrials.gov/study/NCT04373057 |