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Prebiotic Galacto-oligosaccharide and Acute GVHD

A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD

Who can join

Ages 18 to 80 · All sexes

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

About the study

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.

What is being tested

• Galacto-oligosaccharide (dietary supplement)
• Maltodextrin (dietary supplement)

Sponsor: University of Kansas Medical Center · Participants: 128 · Started: Jan 22, 2021

Contact the study team

• Beth Turk, MPH, CCRC · Phone: (913) 574-0154

Official record on ClinicalTrials.gov — NCT04373057

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.