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Treatment and Resistance Of Helicobacter Pylori in Waitemata, Auckland

Treatment and Resistance Of Helicobacter Pylori in Symptomatic Patients in Waitemata, Auckland

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000169448
Enrollment
100
Registered
2025-02-13
Start date
2025-02-17
Completion date
2027-02-03
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

We are aiming to review the resistance and treatment success, and factors associated with this, of a common bacteria, Helicobacter pylori in patients coming for investigation with gastroscopy of abdominal complaints. We hope to be able to use this data to update treatment guidelines.

Interventions

A single centre prospective study of consecutive patients attending for gastroscopy who have biopsies to assess for Helicobacter Pylori (H. pylori) (clinician discretion) . Questionnaire provided: 15 questions assessing demographic data and socioeconomic data points which takes 5-10 minutes to fill. This is completed before the biopsy below. Gastroscopy performed. 2x gastric biopsies obtained from the antrum and body for immediate urease testing. The urease test, also known as CLO testing (ca

A single centre prospective study of consecutive patients attending for gastroscopy who have biopsies to assess for Helicobacter Pylori (H. pylori) (clinician discretion) . Questionnaire provided: 15 questions assessing demographic data and socioeconomic data points which takes 5-10 minutes to fill. This is completed before the biopsy below. Gastroscopy performed. 2x gastric biopsies obtained from the antrum and body for immediate urease testing. The urease test, also known as CLO testing (campylobacter-like organism test) is a rapid, sensitive and cost-effective test. This is held at ambient air temperature and read within 60 minutes for positivity. 4 further biopsies (2 from antrum, 2 from body) obtained for culture and placed into 1 ml of brain-heart infusion (BHI) broth, labelled with patient information and refrigerated. This is sent to microbiology department at Middlemore Hospital within 24 hours if the Urease test is positive, otherwise it is discarded. Positive CLO samples are sent to the Malaghan Institute of Medical Research, Wellington, for polymerase chain reaction (PCR) testing. Phenotypic resistance to each antibiotic will be determined by detecting specific mutations which typically alter the uptake or efflux of the antibiotic. DNA extraction will be performed using a commercially available DNA extraction kits. The DNA will be stored at -80°C until testing is performed. The presence of H. pylori DNA will be confirmed using PCR. Molecular testing for mutations conferring antimicrobial resistance will be tested using droplet digital PCR. Duration of observation for each participant will be from time of enrolment for 12 months

Sponsors

Te Whatu Ora - Waitemata
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Attendance for a gastroscopy where there is a clinical suspicion H.pylori may be contributory to the presentation and biopsies are likely to be taken to test for H.pylori infection.

Exclusion criteria

• Contraindication to biopsy • Unable to provide consent • Previous H.pylori eradication regimen prescribed

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026