Actively Recruiting

Phase Not Applicable
Age: 6Years - 18Years
All Genders
ID03365609

Comparison of Four Treatment Regimens as First-Line Therapy for Helicobacter pylori Infection in Chinese Children Including Resistance and Impact Factor Studies in a Multicenter Trial

Led by Ying HUANG · Updated on 2025-02-28

1440

Participants Needed

1

Research Sites

432 weeks

Total Duration

On this page

Sponsors

Y

Ying HUANG

Lead Sponsor

G

Guangzhou Women and Children's Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating four different treatment plans as the first choice for Helicobacter pylori infection in Chinese children aged 6 to 18 years. This study addresses the challenge of increasing resistance to standard treatments and aims to find the most effective regimen among triple therapy, sequential therapy, bismuth quadruple therapy, and concomitant therapy. The study also investigates factors influencing resistance and how these treatments affect the balance of bacteria in the gut. Children who qualify for the study are randomly assigned to one of four treatment groups. The triple therapy group receives Omeprazole, Amoxicillin, and Clarithromycin for 14 days. The sequential therapy group takes Omeprazole and Amoxicillin for the first 7 days, then Omeprazole, Clarithromycin, and Metronidazole for the last 7 days. The bismuth quadruple therapy group is treated with Omeprazole, Amoxicillin, Metronidazole, and Colloidal Bismuth Subcitrate for 14 days. The concomitant therapy group receives Omeprazole, Amoxicillin, Clarithromycin, and Metronidazole together for 14 days. During the study, researchers check if the infection is cleared 4 to 6 weeks after treatment using a breath test called 13C-UBT. They also monitor side effects, factors that might affect treatment success, and changes in the gut microbiome. The results will help develop guidelines for diagnosing and treating Helicobacter pylori in Chinese children, aiming to improve cure rates and reduce antibiotic resistance.

CONDITIONS

Official Title

A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 18 years
  • Confirmed Helicobacter pylori infection by upper endoscopy
Not Eligible

You will not qualify if you...

  • Use of proton pump inhibitors, H2-receptor antagonists, or antibiotics within 4 weeks prior to study
  • Known allergy to antibiotics
  • Liver impairment
  • Kidney failure
  • Previous treatment for Helicobacter pylori infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

Y

Ying Zhou, master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016).

Nicola L Jones, Sibylle Koletzko, Karen Goodman...

https://pubmed.ncbi.nlm.nih.gov/28541262