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Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1

RECRUITINGPhase 4Sponsored by University of Miami
Actively Recruiting
PhasePhase 4
SponsorUniversity of Miami
Started2022-10-15
Est. completion2027-11-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Gastric CancerH Pylori GastritisH Pylori Infection

Locations1 site

University of Miami
Miami, Florida, 33136
Sarahane Joanem3052434147Hpyloristudy@miami.edu

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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