Clinical trial Recruiting at 1 site Interventional Ages 6 to 18

Comparing four treatments for Helicobacter pylori in Chinese children

Official title: A Comparison of Four Different Treatment Regimens as the First-line Treatment of Helicobacter Pylori in Chinese Children and Investigation of Resistance and Impact factors-a Multicenter Study

Run by Children's Hospital of Fudan University · NCT03365609 · Data updated 2026-11-12

This study is testing four different treatments for Helicobacter pylori infection in Chinese children to see which one works best.

More HELICOBACTER PYLORI INFECTIONS trials

Quick facts

Study typeInterventional
Ages6 Years to 18 Years
SexAll
Enrollment1440 (estimated)
SponsorChildren's Hospital of Fudan University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 20, 2017
Main results expectedOctober 1, 2025
Study endsDecember 31, 2025
Registry record updatedFebruary 28, 2025
Trial IDNCT03365609 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 6-18 years who have been diagnosed with Helicobacter pylori infection and are referred for upper endoscopy.

Probably not a fit

Patients who have taken proton pump inhibitors, H2-receptor antagonists, or antibiotics in the four weeks prior to the study, or those with known antibiotic allergies, hepatic impairment, or kidney failure may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of four different treatment regimens for Helicobacter pylori infection in Chinese children, including standard triple therapy, sequential therapy, bismuth quadruple therapy, and concomitant therapy. Eligible participants, aged 6 to 18, will be randomly assigned to one of the treatment groups for a 14-day course. The primary outcome will be the eradication rate of Helicobacter pylori, assessed 4-6 weeks post-treatment, while secondary outcomes will evaluate side effects, influencing factors, and changes in microbiota. The findings are expected to inform new guidelines for diagnosing and treating Helicobacter pylori in pediatric populations in China.

Why it matters

Potential benefit: If successful, this study could significantly improve the treatment outcomes for Helicobacter pylori infections in Chinese children.

How similar studies have gone: While there have been studies on Helicobacter pylori treatment, this specific comparison of regimens in Chinese children is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection

Exclusion Criteria:

* patients were excluded if they had taken proton pump inhibitors, H2-receptor antagonists or antibiotics in the 4 weeks prior to the study. Patients with known antibiotic allergy,hepatic impairment or kidney failure were also excluded. Patients who received Hp therapy before were also excluded.

Where it's running

  • Children's hospital of Fudan university
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.