Graft Versus Host Disease, Hematopoietic Cell Transplantation Recipient
Conditions
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Interventions
OTHERDietary Intervention
Undergo gluten free diet
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples | Up to 12 months post allo-SCT | To determine how often patients develop gastrointestinal graft-versus-host disease at various times after transplant |
| Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples | Up to 12 months post allo-SCT | To determine what the severity is if graft-versus host disease develops. |
| Rate of compliance with GFD | Up to 30 days | Adherence to diet will be recorded in a food diary. Compliance will be defined as \> 67% of meals being gluten free. |
Countries
United States
Outcome results
None listed