Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
NCT ID: NCT03102060
Last Updated: 2021-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2017-08-22
2018-06-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Dietary Intervention
Undergo gluten free diet
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Dietary Intervention
Undergo gluten free diet
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No history of celiac disease or non-celiac gluten sensitivity
* Male and female and all ethnic groups are eligible
Exclusion Criteria
* Children are not eligible as the transplant program is certified as an adult only transplant program
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Roger Strair, MD, PhD
Associate Professor
Principal Investigators
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Roger Strair
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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NCI-2017-00438
Identifier Type: REGISTRY
Identifier Source: secondary_id
021701
Identifier Type: OTHER
Identifier Source: secondary_id
Pro20170000304
Identifier Type: -
Identifier Source: org_study_id
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