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

Graft Versus Host Disease Clinical Trial

Official title:

Gluten Free Diet for GVHD Prophylaxis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03102060
• Other study ID #: Pro20170000304
• Secondary ID: NCI-2017-0043802
• Status: Terminated
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: June 11, 2018

Study information

• Verified date: August 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease
• Hematopoietic Cell Transplantation Recipient

Intervention

Other:
• Dietary Intervention
Undergo gluten free diet
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples	To determine how often patients develop gastrointestinal graft-versus-host disease at various times after transplant	Up to 12 months post allo-SCT
Primary	Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples	To determine what the severity is if graft-versus host disease develops.	Up to 12 months post allo-SCT
Primary	Rate of compliance with GFD	Adherence to diet will be recorded in a food diary. Compliance will be defined as > 67% of meals being gluten free.	Up to 30 days