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Prebiotic Galacto-oligosaccharide for Acute GVHD

This study is looking at whether a dietary supplement called galacto-oligosaccharide (GOS) can help prevent acute graft-versus-host disease (GVHD) after a stem cell transplant. GVHD is a serious complication where the new immune cells attack the patient's body. Researchers believe GOS might work by changing the bacteria in your gut (your microbiome), which can affect your immune system. The study will first find the best dose of GOS. Then, participants will either receive GOS or a placebo (maltodextrin, a common food additive) to see if GOS reduces the risk of GVHD. The study aims to enroll 128 participants aged 18 to 80 who are planning to have a stem cell transplant and are generally in good health. Success would mean finding a safe dose of GOS and seeing a lower rate of severe GVHD.

Study design
This is an interventional study with two parts. In the second part, participants will be randomly assigned to receive either GOS or a placebo.
What's involved
You would take GOS or maltodextrin once daily starting about 30 days before your transplant and continuing for about 4 weeks after your transplant.
Compensation
Not stated in the trial record.
Follow-up
The study will track the incidence of severe GVHD up to 100 days after transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04373057

Prebiotic Galacto-oligosaccharide and Acute GVHD

Recruiting
PHASE1Ages 18–80InterventionalPrevention
University of Kansas Medical Center
~128 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Galacto-oligosaccharideMaltodextrin

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
provisional Maximum Tolerated Dose (pMTD) of GOS
Measured over 30 days
+1 more outcome measured

Conditions

Acute GVHD

Explore related trials

Graft Versus Host Disease

Where it's being run

2 sites across 2 states
Kansas1
North Carolina1

Study leadership

  • Anthony Sung, MD · PRINCIPAL_INVESTIGATOR · University of Kansas
  • Mitchell Horwitz, MD · PRINCIPAL_INVESTIGATOR · Duke Health

Who to contact

Beth Turk, MPH, CCRC
[email protected]
(913) 574-0154
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Plan to undergo allogeneic HCT for any cancer or non-cancer illness
Age 18-80 years
Karnofsky Performance Status \>70

Exclusion

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

What this trial measures

  • provisional Maximum Tolerated Dose (pMTD) of GOS30 days

    GOS will be dosed as outlined using a modified 3+3 design: 0.75g x 4 days, followed by 1.5g x 4 days, followed by 2.9g for the duration of the study. If two or more subjects experience new grade 2 or 3 pre-HCT toxicities at a given dose level, that dose will be considered not tolerable and the previous dose pMTD. If two or more subjects experience new grade 2 or higher pre-HCT toxicities at the 0.75g/day dose, study may be paused to revisit the design. If one subject experiences new grade 2 or 3 pre-HCT toxicities at a given dose level, additional 3 subjects will be enrolled at this same dose schedule. If one or more of these additional subjects experience new grade 2 or 3 pre-HCT toxicities at that same or lower dose level, this dose level will be considered not tolerable and the previous dose the pMTD. If no subjects experience new grade 2 or 3 pre-HCT toxicities or only one of six subjects experience new grade 2 or 3 pre-HCT toxicities, 2.9g/day dose will be assumed to be the pMTD

  • Incidence of Grade II-IV acute GVHD at Day 100100 days

    Acute GVHD Scoring will be done following BMT CTN, 2013 criteria.