Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1 (NCT07224035) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
United States500 participantsStarted 2022-10-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
What they're measuring
1
Percent of participants diagnosed with Helicobacter pylori using PYTEST® breath test at baseline