Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00584259
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003069', 'term': 'Coffee'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-12', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'coffee leads to reflux events', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'Gastro-Esophageal Disease'], 'conditions': ['GERD']}, 'descriptionModule': {'briefSummary': 'Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.', 'detailedDescription': 'Many patients with gastro-esophageal reflux disease (GERD) report that drinking coffee causes heartburn. The purpose of this study is to investigate the effects of coffee on gastro-esophageal acid reflux, and its relation to esophageal motility parameters in patients who are already scheduled to undergo 48 hour wireless pH testing as a result of having symptoms suggestive of GERD. The specific aims are to evaluate the effects of coffee on GERD during daily life and to elucidate the underlying pathogenic mechanism by which coffee induces reflux.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persons undergoing wireless pH testing for diagnosis and treatment of GERD\n\nExclusion Criteria:\n\n* those under the age of 18\n* pregnant and lactating women\n* those who do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00584259', 'briefTitle': 'Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux', 'orgStudyIdInfo': {'id': '200614348-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coffee', 'type': 'OTHER', 'description': '3 cups of coffee over a 24 hour period'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Peter Belafsky, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Peter Belafsky, MD, Ph.D.', 'oldOrganization': 'University of California Davis'}}}}