Helicobacter Pylori determination in a Fecal Immunochemical Test (FIT) - a proof of concept

Completed

• Conditions: Campylobacter pyloridis; gastric bacterium; 10017966

• Registration Number: NL-OMON50384
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 284

Inclusion Criteria

- Referred for an urea breath test via the outpatient clinic of the Erasmus MC,
Albert Schweitzer Hospital or Maasstad Hospital
OR
- Staff working at the endoscopy department of the Erasmus MC and at risk for
having a H. Pylori infection, such as gastroenterologists, endoscopy nurses,
and laboratory assistants.

Exclusion Criteria

Use of antibiotics/bismuth in the past 4 weeks
Use of PPI in the past 2 weeks

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. PR, PPV/NPV, sensitivity and specificity of H. pylori determination in FIT,<br /><br>compared to UBT<br /><br>2. Differences in test performances before and after eradication therapy for<br /><br>UBT, stool antigen assay (SAT) and FIT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. PR, PPV/NPV, sensitivity and specificity of H. pylori determination in FIT<br /><br>compared to SAT and serology<br /><br>2. PR, PPV/NPV, sensitivity and specificity of SAT and serology, compared to<br /><br>UBT</p><br>