Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-13 @ 12:42 PM
Study NCT ID:
NCT07224035
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2025-10-30', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline', 'timeFrame': 'Baseline', 'description': 'This measure determines the percent of participants who test positive for Helicobacter pylori at baseline. This is done using the PYTEST® 14C-Urea Breath Test. Participants will receive a diagnosis on-site, approximately 30 minutes after administration of urea capsule. This will allow immediate treatment free of charge (VOQUEZNA® Triple Pak®) initiation for positive eligible participants.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['H Pylori Infection', 'H Pylori Gastritis', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'H. pylori is an infection of the stomach that can cause chronic gastritis, gastric cancer and peptic ulcer disease. The goal of this study is to screen people for this infection and offer treatment for those who test positive for the infection. By treating those who are positive for H. pylori, there is an opportunity to prevent gastritis, peptic ulcer disease, and even gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n\nExclusion Criteria:\n\n* Adults with a personal history of gastric cancer\n* Adults with prior history of H. Pylori (HP) treatment and confirmed eradication\n* Adults unable to consent\n* Adults unable to consent in their preferred language\n* Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed\n* Prisoners\n* Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®:\n* vonoprazan\n* amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins)\n* clarithromycin or any other macrolide antimicrobial (e.g. erythromycin)\n* Persons presently taking any of the following:\n* Rilpivirine-containing products\n* Pimozide\n* Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin\n* Ergot alkaloids\n* Colchicine (if with kidney or liver impairment)\n* Lurasidone\n* Drugs known to prolong the QT interval (e.g., pimozide).\n* Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents\n* Verapamil, amlodipine, diltiazem, nifedipine\n* Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin\n* Quetiapine\n* Warfarin\n* Benzodiazepines (e.g. triazolam, midazolam)\n* Persons who have any of the following, as they may be prone to adverse effects from the medication regimen:\n* History of cholestatic jaundice\n* Severe kidney impairment\n* Severe hepatic impairment\n* Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes.\n* Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia\n* Participants with ongoing mononucleosis'}, 'identificationModule': {'nctId': 'NCT07224035', 'briefTitle': 'Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1', 'orgStudyIdInfo': {'id': '20211207-AIM 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Helicobacter Pylori Screening and Treatment', 'description': 'Participants in this single-arm study will undergo screening for Helicobacter pylori (H. pylori) using the PYtest® 14C-Urea Capsule Breath Test. This FDA-approved, non-invasive diagnostic method involves swallowing a radiolabeled urea capsule. If gastric urease from H. pylori is present, the urea is hydrolyzed to produce carbon dioxide and ammonia. Ten minutes after ingestion, a breath sample is collected in a balloon and transferred into a collection fluid to trap the labeled carbon dioxide. The sample is analyzed using a liquid scintillation counter to determine infection status.\n\nParticipants who test positive will receive VOQUEZNA® Triple Pak® therapy, dispensed by the study team at the time of diagnosis. Phathom Pharmaceuticals will supply the medications (which include complete medication package insert), but the study team hold and dispenses medications.', 'interventionNames': ['Drug: PYTEST® 14C-Urea Breath Test', 'Drug: VOQUEZNA® Triple Pak®']}], 'interventions': [{'name': 'PYTEST® 14C-Urea Breath Test', 'type': 'DRUG', 'description': 'FDA-approved radiolabeled urea capsule used in the PYtest® 14C-Urea Breath Test for non-invasive detection of H. pylori. Participants ingest the capsule, and breath samples are collected and analyzed to determine infection status.', 'armGroupLabels': ['Helicobacter Pylori Screening and Treatment']}, {'name': 'VOQUEZNA® Triple Pak®', 'type': 'DRUG', 'description': 'FDA-approved combination therapy for H. pylori infection, consisting of:\n\nVonoprazan tablets 20 mg (1 tablet twice daily for 14 days) Amoxicillin 500 mg (2 tablets twice daily for 14 days) Clarithromycin 500 mg (1 tablet twice daily for 14 days) Medications are dispensed by the study team at the time of diagnosis.', 'armGroupLabels': ['Helicobacter Pylori Screening and Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarahane Joanem', 'role': 'CONTACT', 'email': 'Hpyloristudy@miami.edu', 'phone': '3052434147'}, {'name': 'Angie Gaitan', 'role': 'CONTACT', 'email': 'Hpyloristudy@miami.edu', 'phone': '3052434147'}, {'name': 'Shria Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Sarahane Joanem', 'role': 'CONTACT', 'email': 'Hpyloristudy@miami.edu', 'phone': '3052434147'}, {'name': 'Angie Gaitan', 'role': 'CONTACT', 'email': 'Hpyloristudy@miami.edu', 'phone': '3052434147'}], 'overallOfficials': [{'name': 'Shria Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Phathom Pharmaceuticals', 'class': 'UNKNOWN'}, {'name': 'NRG Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Medicine', 'investigatorFullName': 'Shria Kumar', 'investigatorAffiliation': 'University of Miami'}}}}