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

N/ATerminatedNCT03102060

Rutgers, The State University of New Jersey7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Graft Versus Host Disease Hematopoietic Cell Transplantation Recipient

Interventions

Dietary InterventionOTHER

Undergo gluten free diet

Laboratory Biomarker AnalysisOTHER

Correlative studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: Up to 30 days

Data from ClinicalTrials.gov

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