NCT04373057 Prebiotic Galacto-oligosaccharide and Acute GVHD
| NCT ID | NCT04373057 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Kansas Medical Center |
| Condition | Acute GVHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2021-01-22 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2021-01-22 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Anthony Sung, MD
PRINCIPAL INVESTIGATOR
University of Kansas
Frequently Asked Questions
Who can join the NCT04373057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute GVHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04373057 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04373057 currently recruiting?
Yes, NCT04373057 is actively recruiting participants. Contact the research team at bturk2@kumc.edu for enrollment information.
Where is the NCT04373057 trial being conducted?
This trial is being conducted at Kansas City, United States, Durham, United States.
Who is sponsoring the NCT04373057 clinical trial?
NCT04373057 is sponsored by University of Kansas Medical Center. The principal investigator is Anthony Sung, MD at University of Kansas. The trial plans to enroll 128 participants.