NCT03102060

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

Gluten Free Diet for GVHD Prophylaxis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Versus Host Disease
• Hematopoietic Cell Transplantation Recipient

Interventions

Type	Name	Description
OTHER	Dietary Intervention	Undergo gluten free diet
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-08-22
• Primary completion: 2018-06-11
• Completion: 2018-06-11
• First posted: 2017-04-05
• Last updated: 2021-08-23

Locations

1 site across 1 country: United States