What this study is
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's being tested
- Galacto-oligosaccharide
Intervention · DIETARY SUPPLEMENT
GOS will be administered at determined dose levels per protocol once daily from about 30 days before transplant to about 4 weeks after transplant.
- Maltodextrin
Intervention · DIETARY SUPPLEMENT
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.
Study details
- Official title
- A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
- Sponsor
- University of Kansas Medical Center
- Conditions
- Acute GVHD
- Enrolling
- 128 people
- Starts
- 2021-01-22
- Est. completion
- 2029-02-01
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Plan to undergo allogeneic HCT for any cancer or non-cancer illness
- Age 18-80 years
- Karnofsky Performance Status >70
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
1 openKansas University Medical Center
Kansas City, Kansas, United States
- Anthony Sung, MD · Contact
RecruitingDuke
Durham, North Carolina, United States
Active, not recruiting
Study team
Sponsor
University of Kansas Medical Center
Study ID STUDY00161331
Principal investigator
Anthony Sung, MD
University of Kansas
Principal investigator
Mitchell Horwitz, MD
Duke Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.