Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study

NCT07455448 | Completed

• 1 other identifier: KY20260108-KS-10
• Study Type: observational
• Target: 7,227
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to provide an updated analysis of the resistance patterns of H. pylori in the Nanjing region, with a focus on characterizing the current status of phenotypic and genotypic resistance to these six antimicrobial agents. The findings are expected to offer a scientific basis for the rapid diagnosis and personalized treatment of H. pylori infection.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori; Antibiotics; Nanjing

Outcome Measures

Primary Outcomes (1)

• Phenotypic Antibiotic Resistance Rate

  Description: Resistance rate for each antibiotic (amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and furazolidone) as determined by phenotypic antimicrobial susceptibility testing. Unit of Measure: Percentage (%) Aggregation: Resistance rate will be calculated as the number of patients resistant to a specific antibiotic divided by the total number of patients tested for that antibiotic.

  April to May 2026

Secondary Outcomes (1)

• Genotypic Mutation Rate

  April to May 2026

Interventions

Antimicrobial susceptibility testing DIAGNOSTIC_TEST

This study employed a retrospective, single-center, cross-sectional epidemiological design. Medical records of outpatients who underwent H. pylori culture and genetic testing at the gastroenterology clinic between 2018 and 2025 were retrospectively reviewed. The study aimed to characterize the resistance patterns of H. pylori in the Nanjing region, with a focus on elucidating the current status of phenotypic and genotypic resistance to amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline, and furazolidone. The findings are intended to assist clinicians in the rapid diagnosis and individualized treatment of H. pylori infection.

Also known as: PCR-based genetic analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient records were retrieved from the electronic medical record system and laboratory information system of Nanjing First Hospital. The search identified all outpatients who underwent H. pylori culture and genetic testing at the gastroenterology clinic between January 1, 2018, and December 31, 2024, according to pre-defined inclusion and exclusion criteria.

You may qualify if:

• Patients who visited the Gastroenterology Department of Nanjing First Hospital and underwent gastroscopy with H. pylori culture and genetic testing between 2018 and 2024.
• Positive for H. pylori by at least one diagnostic method (13C-urea breath test, rapid urease test, or histopathology).
• Provision of general written informed consent for the use of gastroscopy and specimen data in research.
• Availability of complete medical records and laboratory test results.

You may not qualify if:

• Withdrawal of informed consent; use of antibiotics, proton pump inhibitors, H2-receptor antagonists, or bismuth agents within four weeks prior to gastroscopy.
• History of gastric surgery.
• Incomplete medical records or test results precluding evaluation.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)