Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-02 @ 1:10 AM
Study NCT ID:
NCT04506593
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2016-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indiana University Gastrointestinal Motility Diagnosis Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D014839', 'term': 'Vomiting'}], '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'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2016-07-16', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of patients by accurate motility diagnosis', 'timeFrame': '.through study completion, an average of 10 years', 'description': 'Motility diagnosis will be made by physicians with specialized in GI Motility, based on consensus diagnostic criteria. The information gathered from the database will be used to help promote future clinical development and research in GI motility disorders.'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)', 'timeFrame': 'through study completion, an average of 10 years', 'description': 'SIBO-disease specific patient questionnaire will be compared between patients with aerodigestive tract SIBO and coliform SIBO'}, {'measure': 'Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis', 'timeFrame': 'through study completion, an average of 10 years', 'description': 'Patient Assessment of GI - Symptom (PAGI-SYM) scores will be compared between patients with emesis-predominant, dyspeptic-predominant, and regurgitation-predominant gastroparesis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eosinophilic esophagitis', 'Chronic intestinal pseudo-obstruction', 'Small Bowel dysmotility', 'SIBO', 'Vomiting', 'Functional dyspepsia', 'Functional bloating', 'Gastroparesis'], 'conditions': ['Eosinophilic Esophagitis', 'Gastroesophageal Reflux Disease (GERD)', 'Gastroparesis', 'Functional Vomiting', 'Irritable Bowel Syndrome (IBS)', 'Constipation', 'Chronic Intestinal Pseudo-obstruction', 'Fecal Incontinence', 'Small Intestinal Bacterial Overgrowth']}, 'descriptionModule': {'briefSummary': 'Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders', 'detailedDescription': 'Develop a registry (list of patients) of patients seen the clinics with motility disorders. Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis will be made by physicians with specialized in GI Motility, based on clinical consensus of diagnostic criteria. The information gathered from the database will be used to help promote future clinical research in the GI motility and Neurogastroenterology Unit at Indiana University School of Medicine.\n\nGastrointestinal motility symptoms are very common. It encompasses a wide range of problems, such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension, weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is essential in order to promote cost-effective treatment and future research to benefit patients with GI motility disorders\n\nSpecific Aims\n\n1. Primary Aim: Identification of patients by accurate motility diagnosis\n2. Secondary Aims:\n\n 1. To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)\n 2. To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology\n2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table\n\nExclusion Criteria:\n\n1\\. Coexisting medical conditions that may limiting participation in clinical research trial'}, 'identificationModule': {'nctId': 'NCT04506593', 'briefTitle': 'Indiana University Gastrointestinal Motility Diagnosis Registry', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Gastrointestinal Motility Diagnosis Registry', 'orgStudyIdInfo': {'id': 'GI Database'}, 'secondaryIdInfos': [{'id': '1403899260', 'type': 'OTHER', 'domain': 'Indiana University IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lainna Cohen, MSW', 'role': 'CONTACT', 'email': 'larcohen@iu.edu', 'phone': '317-278-0621'}, {'name': 'Maureen Schilling', 'role': 'CONTACT', 'email': 'maschi@iu.edu'}, {'name': 'Thomas V Nowak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Wo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joel Wittles, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Robert Siwiec, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Toyia J Stevenson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Akira Saito, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Montero, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Indiana University Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Lainna Cohen', 'role': 'CONTACT', 'email': 'larcohen@iu.edu', 'phone': '3172780621'}, {'name': 'Maureen Schilling', 'role': 'CONTACT', 'email': 'maschi@iu.edu'}], 'overallOfficials': [{'name': 'John m Wo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'observational registry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit', 'investigatorFullName': 'John M. Wo', 'investigatorAffiliation': 'Indiana University'}}}}