Status:
WITHDRAWN
Sensitivity and Specificity of the Modified Helicobacter Test INFAI
Lead Sponsor:
International Pharmaceutical Consultancy
Conditions:
Dyspepsia
GERD
Eligibility:
All Genders
18+ years
Brief 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 specificit...
Detailed Description
Helicobacter pylori (H. pylori) infection can be diagnosed by invasive (i.e., endoscopy and biopsy) and non-invasive techniques . The most accurate non-invasive tests for diagnosing active H. pylori a...
Eligibility Criteria
Inclusion
- Male and female patients of at least 18 years of age.
- All acid-related disorders requiring long-term PPI treatment including functional dyspepsia according Rome IV classification.
- Positive or negative standard 13C-UBT at screening.
- Diagnosis of H. pylori infection confirmed or excluded by combination of culture , histology and rapid\*\* urease test (PyloriTek@, Serim Research Corp., Elkhart, IN, USA) on samples obtained by endoscopy:
- True positive if culture positive and/or positive histology in combination with positive urease test.
- True negative if culture is negative and if histology and/or urease test is negative. True negative if culture not evaluable and both histology and urease test are negative.
- Culture will be based on biopsies from antrum and corpus. Two biopsies will be taken from antrum and corpus for histology. Rapid urease test will be performed on the samples of antrum and corpus. Written informed consent of the patient.
Exclusion
- Previous H. pylori eradication therapy.
- Intake of PPI off 14 days, 1-12 receptor antagonists 1 day, NSAlDs, antibiotics, antisecretory drugs, bismuth compounds, or sucralfate in the 4 weeks prior to enrolment.
- Manifest coagulopathy or any other disorder according to which endoscopy and/or biopsies are contraindicated.
- Participation in a clinical trial with another not approved drug within 30 days before entering the study and/or previous participation in this study.
- Pregnancy
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04294823
Start Date
November 1 2020
End Date
February 1 2021
Last Update
September 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHI de créteil
Créteil, Val De Marne, France, 94000