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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

Información sobre este estudio

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. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20338058

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