Prebiotic Galacto-oligosaccharide and Acute GVHD

Description

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.

Conditions

Acute GVHD

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Study Overview

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Study Details

Study overview

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.

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

Prebiotic Galacto-oligosaccharide and Acute GVHD

Condition
Acute GVHD
Intervention / Treatment

-

Contacts and Locations

Durham

Duke, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Plan to undergo allogeneic HCT for any cancer or non-cancer illness
  • * Age 18-80 years
  • * Karnofsky Performance Status \>70
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Mitchell Horwitz, MD, PRINCIPAL_INVESTIGATOR, Duke Health

Anthony Sung, MD, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

2028-02-01