Ph I/II of GOS in acute GVHD (Stem Cell Transplantation) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if taking a prebiotic (dietary supplement) can reduce the risk of acute graft-versus-host disease (a common complication) in people who receive an allogeneic stem cell transplant. This study is important because prebiotics are a common and safe dietary supplement, and there is a need for a safe and effective way to reduce graft-versus-host disease after transplant.

What is the Condition Being Studied?

Allogeneic (Donor) Stem Cell Transplant

Who Can Participate in the Study?

Adults ages 18-80 who:
- Are scheduled to get an allogeneic stem cell transplant for any type of illness
- Are able to read and write in English
- Are not pregnant or nursing
- Do not have any disease or condition affecting their digestive tract
- Are not using any prebiotic, probiotic, or antibiotic

For more information about who can join this study, please contact the study team at andrea.pires@duke.edu or 919-668-4978.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:
-Be randomly asssigned (like a coin flip) to receive the prebiotic (food additive that affects gut bacteria) or a placebo (food additive that does not affect gut bacteria)
- Give stool samples
- Have your skin swabbed
- Have blood draws
- Fill out questionnaires
- Have Cardiopulmonary Exercise Testing (CPET) done
- Have complete body composition testing done
- Have muscle and fat composition testing done using a hand-held ultrasound device
- Complete physical function and cognitive function assessments

Study Details

Full Title
IIT: A Phase I/II Trial of the prebiotic galacto-oligosaccharide to prevent Acute GVHD
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00105137
NCT: NCT04373057
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698