Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
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ClinicalTrials.gov Identifier: NCT03102060 |
Recruitment Status :
Terminated
(Slow accrual)
First Posted : April 5, 2017
Last Update Posted : June 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft Versus Host Disease Hematopoietic Cell Transplantation Recipient | Other: Dietary Intervention Other: Laboratory Biomarker Analysis | Not Applicable |
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 : | 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 |

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:
Other: Laboratory Biomarker Analysis Correlative studies |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
United States, New Jersey | |
Rutgers Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 |
Principal Investigator: | Roger Strair | Rutgers Cancer Institute of New Jersey |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Graft vs Host Disease Immune System Diseases |