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Prebiotic

Prebiotic Supplement for Acute GVHD

Phase 1 & 2

Recruiting

Led By Anthony Sung, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Status >70

Age 18-80 years

Must not have

At time of enrollment, Grade 2 or higher GI symptoms per NCI-CTCAE

Malabsorption syndrome, short bowel or chologenic diarrhea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100, day 365, and day 730

Summary

This trial is testing whether a dietary supplement can help prevent a complication from stem cell transplant.

Who is the study for?

Adults aged 18-80 planning to undergo a stem cell transplant for cancer or other illnesses, with a good performance status. Not eligible if using antibiotics (except prophylactic), prebiotics, probiotics, herbal supplements unless stopped before joining; also excluded if pregnant/lactating, have certain digestive conditions, or are in specific other GVHD trials.

What is being tested?

The trial is testing galacto-oligosaccharide (GOS), a dietary supplement thought to improve gut bacteria and prevent graft-versus-host disease after stem cell transplants. Participants will first help find the best dose of GOS and then be randomly given either GOS or maltodextrin (placebo) to see its effects.

What are the potential side effects?

Potential side effects are not detailed here but could include typical reactions to dietary supplements such as digestive discomfort. Since GOS aims to modulate gut bacteria, there may be changes in bowel habits or abdominal pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself and carry out daily activities.

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I am between 18 and 80 years old.

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I am planning to have a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing moderate to severe stomach or intestinal issues.

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I have a condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100, day 365, and day 730

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100, day 365, and day 730

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100, day 365, and day 730 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Grade II-IV acute GVHD at Day 100

provisional Maximum Tolerated Dose (pMTD) of GOS

Secondary study objectives

Health care utilization through Day 100, through Day 365, and through Day 730

Incidence of acute GI toxicities through Day 30

Incidence of chronic GVHD at Day 365 and Day 730

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Galacto-oligosaccharideExperimental Treatment1 Intervention

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.

Group II: MaltodextrinPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Galacto-oligosaccharide

2021

N/A

~60

0 / 5Eligibility criteria met