Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-07 @ 6:12 AM
Study NCT ID:
NCT03102060
Status:
TERMINATED
Last Update Posted:
2021-08-23
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-03-30', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples', 'timeFrame': 'Up to 12 months post allo-SCT', 'description': 'To determine how often patients develop gastrointestinal graft-versus-host disease at various times after transplant'}, {'measure': 'Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples', 'timeFrame': 'Up to 12 months post allo-SCT', 'description': 'To determine what the severity is if graft-versus host disease develops.'}, {'measure': 'Rate of compliance with GFD', 'timeFrame': 'Up to 30 days', 'description': 'Adherence to diet will be recorded in a food diary. Compliance will be defined as \\> 67% of meals being gluten free.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graft Versus Host Disease', 'Hematopoietic Cell Transplantation Recipient']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the tolerance of, and compliance with, a GFD in patients undergoing allogeneic hematopoietic stem cell transplant (allo-SCT).\n\nOUTLINE:\n\nPatients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.\n\nAfter completion of study, patients are followed up at 1, 3, 6, and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing an allo-SCT\n* No history of celiac disease or non-celiac gluten sensitivity\n* Male and female and all ethnic groups are eligible\n\nExclusion Criteria:\n\n* Pregnant women\n* Children are not eligible as the transplant program is certified as an adult only transplant program'}, 'identificationModule': {'nctId': 'NCT03102060', 'briefTitle': 'Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Gluten Free Diet for GVHD Prophylaxis', 'orgStudyIdInfo': {'id': 'Pro20170000304'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00438', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '021701', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}, {'id': 'P30CA072720', 'link': 'https://reporter.nih.gov/quickSearch/P30CA072720', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention (gluten free diet)', 'description': 'Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.', 'interventionNames': ['Other: Dietary Intervention', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'OTHER', 'otherNames': ['Dietary Modification', 'intervention, dietary', 'Nutrition Intervention', 'Nutrition Interventions', 'Nutritional Interventions'], 'description': 'Undergo gluten free diet', 'armGroupLabels': ['Prevention (gluten free diet)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Prevention (gluten free diet)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Roger Strair', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Roger Strair, MD, PhD', 'investigatorAffiliation': 'Rutgers Cancer Institute of New Jersey'}}}}