Actively Recruiting
Prebiotic Galacto-oligosaccharide and Acute GVHD
Led by University of Kansas Medical Center · Updated on 2026-04-22
128
Participants Needed
2
Research Sites
418 weeks
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prebiotic Galacto-oligosaccharide and Acute GVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Plan to undergo allogeneic hematopoietic cell transplant (HCT) for any cancer or non-cancer illness
- Age between 18 and 80 years
- Karnofsky Performance Status greater than 70
You will not qualify if you...
- Pregnant or breastfeeding
- Have malabsorption syndrome, short bowel, or chologenic diarrhea
- Have Grade 2 or higher gastrointestinal symptoms at enrollment
- Currently using other prebiotics, probiotics, or herbal supplements (must stop before enrollment)
- Currently on antibiotics except for preventive antibiotics
- Enrolled in another clinical trial targeting GVHD, except observational or non-drug intervention studies
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
2
Duke
Durham, North Carolina, United States, 27710
Active, Not Recruiting
Research Team
B
Beth Turk, MPH, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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