RECRUITING

Prebiotic Galacto-oligosaccharide and Acute GVHD

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

A Phase I/II Trial of the Prebiotic Galacto-oligosaccharide to Prevent Acute GVHD

Quick Facts

Study Start:2021-01-22
Study Completion:2028-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04373057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Plan to undergo allogeneic HCT for any cancer or non-cancer illness
  2. * Age 18-80 years
  3. * Karnofsky Performance Status \>70
  1. * Pregnant/lactating
  2. * Malabsorption syndrome, short bowel or chologenic diarrhea
  3. * At time of enrollment, Grade 2 or higher GI symptoms per NCI-CTCAE
  4. * Active treatment with other prebiotics, probiotics, or herbal supplementation (ok if stops before enrollment)
  5. * Active treatment with antibiotics (with the exception of prophylactic antibiotics)
  6. * 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

Contacts and Locations

Study Contact

Andrea Pires
CONTACT
9196684978
andrea.pires@duke.edu
Lauren Hill
CONTACT
9196682369
lauren.hill@duke.edu

Principal Investigator

Mitchell Horwitz, MD
PRINCIPAL_INVESTIGATOR
Duke Health
Anthony Sung, MD
PRINCIPAL_INVESTIGATOR
Duke Health

Study Locations (Sites)

Duke
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Mitchell Horwitz, MD, PRINCIPAL_INVESTIGATOR, Duke Health
  • Anthony Sung, MD, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-22
Study Completion Date2028-02-01

Study Record Updates

Study Start Date2021-01-22
Study Completion Date2028-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Acute GVHD