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

Not Applicable

Terminated

• Conditions: Graft Versus Host Disease; Hematopoietic Cell Transplantation Recipient
• Interventions: Other: Dietary Intervention; Other: Laboratory Biomarker Analysis

• Registration Number: NCT03102060
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Study Start: 2017-08-22
• Primary Completion: 2018-06-11
• Study Completion: 2018-06-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (gluten free diet)	Laboratory Biomarker Analysis	Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.
Prevention (gluten free diet)	Dietary Intervention	Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.

Primary Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States