“Helicobacter pylori determination: Evaluation of Existing non-invasive methods and Linkage to Innovation” - The HELI-study -

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25263

Enrollment

184

Registered

2018-02-07

Start date

2018-02-07

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Helicobacter pylori, feces sample, urea breath test Helicobacter pylori, fecestest, ademtest

Interventions

- 2x feces samples - 1x vena punction - 2x questionnaires

Eligibility

Inclusion criteria

Inclusion criteria: - aged 18 years or older - referred for urea breath test

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
To compare the accuracy of H. pylori determination in FIT with golden standard UBT by assessing: Positivity Rate (PR), Positive Predictive Value (PPV), Negative Predictive Value (NPV), sensitivity and specificity	—

Secondary

Measure	Time frame
1. To compare the accuracy of H. pylori determination in FIT with SAT and serology by assessing PPV/NPV, sensitivity/specificity 2. To compare the accuracy of SAT and serology with UBT by assessing PPV/NPV, sensitivity/specificity	—

Contacts

Public ContactS.A.V. Nieuwenburg

s.nieuwenburg@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)