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Prebiotic Galacto-oligosaccharide and Acute GVHD

NCT04373057 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Acute GVHD

Interventions

DIETARY_SUPPLEMENT

Galacto-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_SUPPLEMENT

Maltodextrin

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Anthony Sung, MD · University of Kansas

  • Mitchell Horwitz, MD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2027-06-01
Completion
2029-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04373057 on ClinicalTrials.gov