Clinical trial · Interventional
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
NCT07224035CI-TRIAL-00103437active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| H Pylori Gastritis | — | UNRESOLVED | — |
| H Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PYTEST® 14C-Urea Breath Test | Drug | — | UNRESOLVED |
| VOQUEZNA® Triple Pak® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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. Participants 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®
Primary outcomes (1)
- measure
- Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥ 18 years of age Exclusion Criteria: * Adults with a personal history of gastric cancer * Adults with prior history of H. Pylori (HP) treatment and confirmed eradication * Adults unable to consent * Adults unable to consent in their preferred language * Pregnant women, those who are breastfeeding, or those who are planning to become pregnant/breastfeed * Prisoners * Persons who are allergic, hypersensitive, or unable to take any of the components of the medication regimen VOQUEZNA® Triple Pak®: * vonoprazan * amoxicillin or any other beta-lactams (e.g. penicillins and cephalosporins) * clarithromycin or any other macrolide antimicrobial (e.g. erythromycin) * Persons presently taking any of the following: * Rilpivirine-containing products * Pimozide * Lomitapide, lovastatin, simvastatin, atorvastatin, and pravastatin * Ergot alkaloids * Colchicine (if with kidney or liver impairment) * Lurasidone * Drugs known to prolong the QT interval (e.g., pimozide). * Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents * Verapamil, amlodipine, diltiazem, nifedipine * Nateglinide, pioglitazone, repaglinide, rosiglitazone, and insulin * Quetiapine * Warfarin * Benzodiazepines (e.g. triazolam, midazolam) * Persons who have any of the following, as they may be prone to adverse effects from the medication regimen: * History of cholestatic jaundice * Severe kidney impairment * Severe hepatic impairment * Participants with known prolongation of QT interval, ventricular cardiac arrhythmia, including torsades de pointes. * Participants with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia * Participants with ongoing mononucleosis
References
Publications (0)
Data not yet available
No reference posted for this study.