Prebiotic Galacto-oligosaccharide and Acute GVHD

Launched by DUKE UNIVERSITY · May 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a dietary supplement called galacto-oligosaccharide (GOS) to see if it can help prevent a condition known as graft-versus-host disease (GVHD) after patients receive a stem cell transplant. GVHD occurs when the donor's immune cells attack the recipient's body, which can be a serious complication. The trial has two parts: the first part will find the best dose of GOS to use, and the second part will compare the effects of this dose to a placebo, which is a harmless substance that looks like GOS but doesn’t have any active ingredients.

To participate in this trial, you need to be between 18 and 80 years old and planning to undergo an allogeneic stem cell transplant for either cancer or a non-cancer illness. You should also be in fairly good health, as indicated by a performance score. However, if you are pregnant, have certain digestive issues, or are currently taking other similar supplements or antibiotics, you may not be eligible. If you join the trial, you can expect to receive either GOS or the placebo and will help researchers learn more about how this supplement might affect the gut bacteria and potentially improve outcomes after a transplant.

Gender

ALL

Eligibility criteria

• 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 pharmacologic or cellular therapy trials with other targets (for example, NK DLI) are NOT excluded