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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100, day 365, and day 730

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Grade II-IV acute GVHD at Day 100

provisional Maximum Tolerated Dose (pMTD) of GOS

Secondary outcome measures

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,360 Previous Clinical Trials

3,420,202 Total Patients Enrolled

Anthony Sung, MDPrincipal InvestigatorDuke Health

9 Previous Clinical Trials

574 Total Patients Enrolled

Media Library

Galacto-oligosaccharide (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04373057 — Phase 1 & 2

Acute Graft-versus-Host Disease Research Study Groups: Galacto-oligosaccharide, Maltodextrin

Acute Graft-versus-Host Disease Clinical Trial 2023: Galacto-oligosaccharide Highlights & Side Effects. Trial Name: NCT04373057 — Phase 1 & 2

Galacto-oligosaccharide (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04373057 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being accepted for this research endeavor?

"Data accessible on clinicaltrials.gov affirms that this is an ongoing endeavour, which began being advertised on the 22nd of January 2021 and was most recently refreshed on the 22nd of September 2022."

Answered by AI

What set of goals is this medical trial striving to achieve?

"Within a month-long timespan, this study aims to quantify the prevalence of grade II-IV acute GVHD at day 100. Secondary objectives include measuring acute GI toxicities through Day 30 as assessed by CTCAE v5., self-reported evaluations of different symptoms on a 5 point ordinal scale per PRO-CTCAE and chronic GVHD scoring following NIH consensus criteria at both 365 days and 730 days post treatment."

Answered by AI

Might I be qualified to join this research endeavor?

"This medical trial has a capacity of 128 individuals aged 18 to 80 with acute GVHD. Additional criteria for enrollment include being prepared to receive allogenic HCT, and having a Karnofsky Performance Status greater than 70 points."

Answered by AI

How many individuals have been enlisted in this clinical trial?

"Affirmative, according to clinicaltrials.gov this trial is still recruiting volunteers and has been since January 22nd 2021. The last update was on September 22nd 2022 with the goal of enrolling 128 patients from one site."

Answered by AI

Does this research endeavor accept enrollees under the age of eighty?

"Those interested in participating must be aged 18 to 80; there are 1 additional clinical trial available for minors and two more studies specifically designed for senior citizens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prebiotic Galacto-oligosaccharide and Acute GVHD

2021. "Prebiotic Galacto-oligosaccharide and Acute GVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04373057.

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