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

Primary Purpose

Graft Versus Host Disease, Hematopoietic Cell Transplantation Recipient

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Laboratory Biomarker Analysis
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft Versus Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (gluten free diet)

Arm Description

Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2017
Last Updated
August 20, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03102060
Brief Title
Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
Official Title
Gluten Free Diet for GVHD Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
June 11, 2018 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Hematopoietic Cell Transplantation Recipient

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention (gluten free diet)
Arm Type
Experimental
Arm Description
Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Undergo gluten free diet
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples
Description
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
Title
Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples
Description
To determine what the severity is if graft-versus host disease develops.
Time Frame
Up to 12 months post allo-SCT
Title
Rate of compliance with GFD
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Strair
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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