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

Study Overview
=================
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.

Official Title
-----------------
Gluten Free Diet for GVHD Prophylaxis

Conditions
-----------------
Graft Versus Host Disease, Hematopoietic Cell Transplantation Recipient

Intervention / Treatment
-----------------
* Other: Dietary Intervention
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (gluten free diet)<br>Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge. | Other: Dietary Intervention<br>* Undergo gluten free diet<br>* Other names: Nutritional Interventions;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples | To determine how often patients develop gastrointestinal graft-versus-host disease at various times after transplant | Up to 12 months post allo-SCT | 
| Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples | To determine what the severity is if graft-versus host disease develops. | Up to 12 months post allo-SCT | 
| Rate of compliance with GFD | Adherence to diet will be recorded in a food diary. Compliance will be defined as > 67% of meals being gluten free. | Up to 30 days |