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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

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 5, 2017
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE August 22, 2017
Actual Primary Completion Date June 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
Official Title  ICMJE Gluten Free Diet for GVHD Prophylaxis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Graft Versus Host Disease
  • Hematopoietic Cell Transplantation Recipient
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Other: Dietary Intervention
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 8, 2018)
7
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2017)
70
Actual Study Completion Date  ICMJE June 11, 2018
Actual Primary Completion Date June 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03102060
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roger Strair, MD, PhD, Rutgers Cancer Institute of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Roger Strair Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP