Helicobacter Pylori Screening and Treatment in the At-risk South Florida Community- AIM 1
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Adults ≥ 18 years of age
Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Sarahane Joanem
Hpyloristudy@miami.edu
3052434147
Backup
Angie Gaitan
Hpyloristudy@miami.edu
3052434147
Time Frame
Start Date: 2022-10-15
Estimated Completion Date: 2027-11-06
Participants
Target number of participants: 500
Treatments
Experimental: Helicobacter Pylori Screening and Treatment
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.
Related Therapeutic Areas
Sponsors
Collaborators: Phathom Pharmaceuticals, NRG Oncology
Leads: University of Miami