Recruiting
Phase 1
Phase 2

Galacto-oligosaccharide

Sponsor:

University of Kansas Medical Center

Code:

NCT04373057

Conditions

Acute GVHD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Galacto-oligosaccharide

Maltodextrin

Study Details

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.

Conditions

Acute GVHD

Study ID

NCT04373057

Start date

Jan 22, 2021

Status verified date

Apr, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Galacto-oligosaccharide

Phase I: Subjects will receive GOS, at dose levels 0.75g, 1.5g, and 2.9 g/day administered once daily. GOS will be dosed per the following schedule 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 starting from about 30 days before transplant to about 4 weeks after transplant.

Phase II: Subjects will receive GOS, at dose levels 0.25\*MTD, 0.5\*MTD, and MTD with MTD determined by the phase 1 of the study, once daily from about 30 days before transplant to about 4 weeks after transplant.

placebo comparator: Maltodextrin

Phase II: Subjects will receive maltodextrin at comparable dose level as GOS (in Phase II) once daily from about 30 days before transplant to about 4 weeks after transplant.

Interventions

Galacto-oligosaccharide

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

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.

Primary outcome measure

  • provisional Maximum Tolerated Dose (pMTD) of GOS [ Time Frame: 30 days ]
  • Incidence of Grade II-IV acute GVHD at Day 100 [ Time Frame: 100 days ]

Central Contacts and Locations

Central contacts

Beth Turk, MPH, CCRC

(913) 574-0154bturk2@kumc.edu

Locations

Kansas University Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-04-22.