Comparing four treatments for Helicobacter pylori in Chinese children
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
This study is testing four different treatments for Helicobacter pylori infection in Chinese children to see which one works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1440 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03365609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-18 years who have been diagnosed with Helicobacter pylori infection and are referred for upper endoscopy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Children's hospital of Fudan university — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ying Zhou, master
- Email: nnyyhhs@163.com
- Phone: 13917394900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.