Prebiotic

Galacto-oligosaccharide for Acute Graft-versus-Host Disease

Duke, Durham, NC

Galacto-oligosaccharide +1 morePhase 1 & 2RecruitingLed by Anthony Sung, MDResearch Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Plan to undergo allogeneic HCT for any cancer or non-cancer illness

Karnofsky Performance Status >70

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upday 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.

Eligibility Criteria

Inclusion Criteria

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

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You are planning to have a type of stem cell transplant called allogeneic hematopoietic stem cell transplant for any type of disease, including cancer.

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You are able to perform everyday activities and take care of yourself with little to no assistance.

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.

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,275 Previous Clinical Trials

3,091,819 Total Patients Enrolled

Anthony Sung, MDPrincipal Investigator

Duke 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.