NCT04373057 · Duke University
Prebiotic Galacto-oligosaccharide and Acute GVHD
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
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.
DIETARY_SUPPLEMENT
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 measures
provisional Maximum Tolerated Dose (pMTD) of GOS
Time frame: 30 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 100
Time frame: 100 days
Acute GVHD Scoring will be done following BMT CTN, 2013 criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Kansas City, Kansas
- Durham, North Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations