Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/11/2018 |
| Start Date: | August 22, 2017 |
| End Date: | June 11, 2018 |
Gluten Free Diet for GVHD Prophylaxis
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.
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.
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.
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.
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
We found this trial at
1
site
New Brunswick, New Jersey 08903
Principal Investigator: Roger K. Strair
Phone: 732-235-7298
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