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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Terminated
CT.gov ID
NCT03102060
Collaborator
National Cancer Institute (NCI) (NIH)
7
Enrollment
1
Location
1
Arm
9.6
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary Intervention
  • Other: Laboratory Biomarker Analysis
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Gluten Free Diet for GVHD Prophylaxis
Actual Study Start Date :
Aug 22, 2017
Actual Primary Completion Date :
Jun 11, 2018
Actual Study Completion Date :
Jun 11, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prevention (gluten free diet)

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
Undergo gluten free diet
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Roger Strair, Rutgers Cancer Institute of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roger Strair, MD, PhD, Associate Professor, Rutgers Cancer Institute of New Jersey
    ClinicalTrials.gov Identifier:
    NCT03102060
    Other Study ID Numbers:
    • Pro20170000304
    • NCI-2017-00438
    • 021701
    • P30CA072720
    First Posted:
    Apr 5, 2017
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Aug 23, 2021