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

NCT03102060 | Terminated

• 4 other identifiers: Pro20170000304NCI-2017-00438021701P30CA072720
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease; Hematopoietic Cell Transplantation Recipient

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Prevention (gluten free diet)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis

Interventions

Dietary Intervention OTHER

Undergo gluten free diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Prevention (gluten free diet)

Laboratory Biomarker Analysis OTHER

Correlative studies

Prevention (gluten free diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing an allo-SCT
• No history of celiac disease or non-celiac gluten sensitivity
• Male and female and all ethnic groups are eligible

You may not qualify if:

• Pregnant women
• Children are not eligible as the transplant program is certified as an adult only transplant program

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Roger Strair

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 5, 2017
• Study Start: August 22, 2017
• Primary Completion: June 11, 2018
• Study Completion: June 11, 2018
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

US (1)