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 or 919-668-4978.

Age Group

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 N/A
Enrollment Status
Open for Enrollment