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Sensitivity and Specificity of the Modified Helicobacter Test INFAI

NCT04294823 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-09-10

No results posted yet for this study

Summary

Study to confirm the sensitivity of the C\^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI

Secondary objectives : to compare the sensitivity and specificity of the C\^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking PPI.

to complete the results of the Helicbacter test INFAI using new test meal for H.Pylori in patients with dyspepsia and GERD taking PPI with :

* Histology score for H.Pylori in antrum an corpus using the updated Sydney System
* Sex,
* Age,
* Body Mass Index (BMI)

Conditions

  • Dyspepsia
  • GERD

Interventions

DIAGNOSTIC_TEST

Helicobacter Pylori Diagnostic

Helicobacter Test INFAI with standard test Meal (1g citric acid as test meal and 75 mg C\^13 urea) \+ The C\^13 UBT with the new test (REFEX). All patients will take Nexium mups (40 mg) orally once daily 30 min before breakfast from day 1 to 28.

DEVICE

Vital signs measurments

No description;

DIAGNOSTIC_TEST

endoscopy

Upper endoscopy where 6 biopsy samples will be obtained . Two biopsies will be taken from antrum and corpus for histology. The biopsies will be stained with Haematoxylin \& Eosin and Giemsa stains, and gastritis wilt be scored using the Updated Sydney System 12,13 Two biopsies will be taken from antrum and corpus for rapid urease test (RUT) and two biopsies will be taken from antrum and corpus for culture. All biopsy samples will be analysed in the local laboratory of the centre.

DRUG

Nexium Pill

patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast Nexium mups 40 mg will be discontinued after Day 28.

Sponsors & Collaborators

  • International Pharmaceutical Consultancy

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-01-31
Completion
2021-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294823 on ClinicalTrials.gov