Using a prebiotic to prevent graft-versus-host disease after stem cell transplant
Official title: A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD
Run by University of Kansas Medical Center · NCT04373057 · Data updated 2026-11-12
This study is testing if a prebiotic called GOS can help prevent graft-versus-host disease in people who have had a stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 2 sites (Kansas City, Kansas and 1 other locations) |
| Status | Recruiting |
| Started | January 22, 2021 |
| Main results expected | June 1, 2027 |
| Study ends | February 1, 2029 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT04373057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-80 who are planning to undergo allogeneic hematopoietic cell transplantation for various conditions.
✕Probably not a fit
Patients with active gastrointestinal symptoms or those currently receiving other prebiotics, probiotics, or antibiotics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of galacto-oligosaccharide (GOS), a carbohydrate prebiotic, on the gut microbiome and its potential to prevent graft-versus-host disease (GVHD) following allogeneic stem cell transplantation. The trial consists of two phases: the first phase aims to determine the optimal dosage of GOS, while the second phase involves randomizing participants to receive either GOS or a placebo to assess its effectiveness. By enhancing the gut microbiota, the study seeks to reduce inflammation and improve clinical outcomes related to GVHD.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GVHD in patients undergoing stem cell transplants.
How similar studies have gone: While the approach of using prebiotics to modulate the microbiome is promising, this specific application in preventing GVHD is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Kansas University Medical Center
Kansas City, Kansas, United States Recruiting -
Duke
Durham, North Carolina, United States Active not recruiting
Study contacts
- Principal investigator: Anthony Sung, MD — University of Kansas
- Study coordinator: Beth Turk, MPH, CCRC
- Email: bturk2@kumc.edu
- Phone: (913) 574-0154
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.