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.
Who Can Participate?
Eligibility
Adults ages 18-80 who:<ul>
<li>Are scheduled to get an allogeneic stem cell transplant for any type of illness</li>
<li>Are able to read and write in English</li>
<li>Are not pregnant or nursing</li>
<li>Do not have any disease or condition affecting their digestive tract</li>
<li>Are not using any prebiotic, probiotic, or antibiotic</li></ul>
For more information about who can join this study, please contact the study team at andrea.pires@duke.edu or 919-668-4978.
<li>Are scheduled to get an allogeneic stem cell transplant for any type of illness</li>
<li>Are able to read and write in English</li>
<li>Are not pregnant or nursing</li>
<li>Do not have any disease or condition affecting their digestive tract</li>
<li>Are not using any prebiotic, probiotic, or antibiotic</li></ul>
For more information about who can join this study, please contact the study team at andrea.pires@duke.edu or 919-668-4978.
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join the study, you will:<ul>
<li>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)</li>
<li>Give stool samples</li>
<li>Have your skin swabbed</li>
<li>Have blood draws</li>
<li>Fill out questionnaires
<li>Have Cardiopulmonary Exercise Testing (CPET) done</li>
<li>Have complete body composition testing done</li>
<li>Have muscle and fat composition testing done using a hand-held ultrasound device</li>
<li>Complete physical function and cognitive function assessments</li></ul>
<li>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)</li>
<li>Give stool samples</li>
<li>Have your skin swabbed</li>
<li>Have blood draws</li>
<li>Fill out questionnaires
<li>Have Cardiopulmonary Exercise Testing (CPET) done</li>
<li>Have complete body composition testing done</li>
<li>Have muscle and fat composition testing done using a hand-held ultrasound device</li>
<li>Complete physical function and cognitive function assessments</li></ul>
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
IIT: A Phase I/II Trial of the prebiotic galacto-oligosaccharide to prevent Acute GVHD
Principal Investigator
Mitchell
Horwitz
Protocol Number
PRO00105137
NCT ID
NCT04373057
Phase
N/A
Enrollment Status
Open to Enrollment