Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05482256
Status:
COMPLETED
Last Update Posted:
2025-10-24
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012969', 'term': 'Sodium Fluoride'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mucosal impedance 15 minutes after exposure', 'timeFrame': 'Baseline, 15 minutes after teeth brushing', 'description': 'Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology'}], 'secondaryOutcomes': [{'measure': 'Change in Mucosal impedance 30 minutes after exposure', 'timeFrame': 'Baseline, 30 minutes after teeth brushing', 'description': 'Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology'}, {'measure': 'Change in Mucosal impedance 45 minutes after exposure', 'timeFrame': 'Baseline, 45 minutes after teeth brushing', 'description': 'Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology'}, {'measure': 'Change in Mucosal impedance 60 minutes after exposure', 'timeFrame': 'Baseline, 60 minutes after teeth brushing', 'description': 'Recorded from the High Resolution Esophageal Manometry testing that measures eosinophils on histology'}, {'measure': 'Change in IL-33 levels', 'timeFrame': 'Baseline, approximately 60 minutes after teeth brushing', 'description': 'Measured from esophageal string test eluates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials/cls-20535089', 'label': 'Mayo Clinic - Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal, healthy volunteers.\n* Able to swallow pills.\n\nExclusion Criteria:\n\n* Personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or GERD/reflux.\n* History of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss.\n* Celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection.\n* Gelatin allergy.\n* Use of a toothpaste containing SLS within 2 weeks of the study.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05482256', 'briefTitle': 'A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': '22-003963'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toothpaste detergents with Eosinophilic Esophagitis Testing', 'description': 'Subjects will complete an esophageal string test prior to and after completing a high resolution esophageal manometry then brushing their teeth using Colgate toothpaste.', 'interventionNames': ['Diagnostic Test: Esophageal String Test (EST)', 'Other: Colgate', 'Diagnostic Test: High Resolution Esophageal Manometry (HREM)']}], 'interventions': [{'name': 'Esophageal String Test (EST)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['EnteroTracker'], 'description': 'Non-invasive, FDA-registered sampling method to evaluate eosinophilic inflammation in the esophagus. The EST is performed by having an individual swallow a capsule attached to a string which captures secretions from the esophagus. The end of the string is taped to the cheek and the capsule is swallowed with water. After 1 hour, the EST will be removed, and the string will be processed for laboratory analysis.', 'armGroupLabels': ['Toothpaste detergents with Eosinophilic Esophagitis Testing']}, {'name': 'Colgate', 'type': 'OTHER', 'description': '2 grams of toothpaste (pea sized amount) for 2 minutes', 'armGroupLabels': ['Toothpaste detergents with Eosinophilic Esophagitis Testing']}, {'name': 'High Resolution Esophageal Manometry (HREM)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Thin flexible tube with sensors placed in the nose and swallowed for esophagus placement to conduct reading regarding the lining of the esophagus taken for approximately 10 minutes', 'armGroupLabels': ['Toothpaste detergents with Eosinophilic Esophagitis Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Benjamin Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin L. Wright', 'investigatorAffiliation': 'Mayo Clinic'}}}}