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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102060
Recruitment Status : Terminated (Slow accrual)
First Posted : April 5, 2017
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roger Strair, MD, PhD, Rutgers Cancer Institute of New Jersey

Study Description
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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
Graft Versus Host Disease Hematopoietic Cell Transplantation Recipient Other: Dietary Intervention Other: Laboratory Biomarker Analysis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
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 : August 22, 2017
Actual Primary Completion Date : June 11, 2018
Actual Study Completion Date : June 11, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102060


Locations
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United States, New Jersey
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
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Principal Investigator: Roger Strair Rutgers Cancer Institute of New Jersey
More Information
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Responsible Party: Roger Strair, MD, PhD, Associate Professor, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT03102060    
Other Study ID Numbers: 021701
NCI-2017-00438 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
021701 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases