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
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Sponsor Protocol Number: 17-003948
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
Publications are currently not available