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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50384

Enrollment

284

Registered

2017-12-14

Start date

2018-02-23

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Campylobacter pyloridis gastric bacterium

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. PR, PPV/NPV, sensitivity and specificity of H. pylori determination in FIT, compared to UBT 2. Differences in test performances before and after eradication therapy for UBT, stool antigen assay (SAT) and FIT	—

Secondary

Measure	Time frame
1. PR, PPV/NPV, sensitivity and specificity of H. pylori determination in FIT compared to SAT and serology 2. PR, PPV/NPV, sensitivity and specificity of SAT and serology, compared to UBT	—

Countries

Netherlands

Outcome results