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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 1440 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | September 20, 2017 |
| Main results expected | October 1, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 28, 2025 |
| Trial ID | NCT03365609 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
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Children's hospital of Fudan university
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Ying Zhou, master
- Email: nnyyhhs@163.com
- Phone: 13917394900
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.