Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant

Study Purpose

This pilot clinical trial studies how well a gluten free diet works in preventing graft versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). A gluten free diet may decrease intestinal inflammation and graft versus host disease in patients who are undergoing a donor stem cell transplant.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient undergoing an allo-SCT - No history of celiac disease or non-celiac gluten sensitivity - Male and female and all ethnic groups are eligible

Exclusion Criteria:

- Pregnant women - Children are not eligible as the transplant program is certified as an adult only transplant program

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rutgers, The State University of New Jersey
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Roger Strair
Principal Investigator Affiliation Rutgers Cancer Institute of New Jersey
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Graft Versus Host Disease, Hematopoietic Cell Transplantation Recipient
Additional Details


  • I. To determine the rate and severity of gastrointestinal (GI) graft versus host disease (GVHD) in patients assigned to, and compliant with, a gluten free diet (GFD) during initial transplant hospitalization.
  • I. To determine the tolerance of, and compliance with, a GFD in patients undergoing allogeneic hematopoietic stem cell transplant (allo-SCT).
OUTLINE: Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge. After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey




Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Site Contact

Roger K. Strair


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