Prebiotic Galacto-oligosaccharide and Acute GVHD
Recruiting
Phase 1
Phase 2
Interventional Study
Acute GVHD
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 128 (estimated)
- Sponsor
- University of Kansas Medical Center · Other
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About This Trial
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,…
Trial Locations
Sorted by distance from Kansas
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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 sympt…
Contacts