A Study of the Efficacy of Initial Diagnosis of H Pylori with Tech Lab Quik Chek and Efficacy of H. Pylori Chek on Patients that Have Been Treated for H Pylori

Overview

About this study

The purpose of this study is to evaluate the efficacy of initial diagnosis of H Pylori with Tech Lab Quik Chek and efficacy of H. Pylori Chek on patients that have been treated for H Pylori.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

For initial diagnosis claim: Recruit patients with symptoms of dyspepsia, gastritis, or peptic ulcer who are scheduled to undergo endoscopy with gastric biopsy as part of routine care

Patients with symptoms of dyspepsia, gastritis, or peptic ulcer who are scheduled to undergo endoscopy with gastric biopsy to determine H. pylori infection as part of routine care
Patients that have refrained from antibiotics and bismuth compounds (e.g. Pepto-Bismol) for two weeks prior to submitting a fecal sample
Adult and Pediatric patients

For eradication claim: recruit patients with a previously diagnosed H. pylori infection that have completed an antibiotic treatment regimen and are scheduled to undergo endoscopy with gastric biopsy as part of routine care

Patients previously diagnosed with H. pylori infection by any approved method (CRM, stool antigen test, or urea breath test) and have recently completed an antibiotic treatment regimen that are scheduled to undergo endoscopy with gastric biopsy to verify eradication of the H. pylori infection
Patients that have refrained from antibiotics and bismuth compounds (e.g. Pepto-Bismol) for four weeks prior to submitting a fecal sample
Adult and Pediatric patients

Exclusion Criteria:

For initial diagnosis claim:

Asymptomatic patients
Patients in which the presence/absence of H. pylori is already known
- Less than 3 months for the absence of H. pylori
- Less than 1 year for the presence of H. pylori, without treatment

For eradication claim:

Patients in which the presence/absence of H. pylori is already known
- Less than 3 months for the absence of H. pylori
- Less than 1 year for the presence of H. pylori, without treatment

More information

Publications

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