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NCT Number: NCT03365609

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

With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype. Investigators want to perform a research to compare four different treatment regimens（triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the first-line treatment of Helicobacter pylori in Chinese children and investigation of resistance, impact factors and changes of microbiota after the therapy. The results of the study will provide theoretical basis to make the new guideline of diagnosis and therapy of Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the resistance.

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Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Ying Huang, MD and PhD

CONTACT

[email protected]

13816882247

Ying Zhou

SUB_INVESTIGATOR

About this study

Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

triple therapy

Drug

Omeprazole+Amoxicillin+Clarithromycin

sequential therapy

Drug

the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole

bismuth quadruple therapy

Drug

Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate

concomitant therapy

Drug

Omeprazole+Amoxicillin+Clarithromycin+Metronidazole

Primary outcomes

  1. 13C-UBT

    Time frame: 13C-UBT was assessed at 4-6 weeks after completion of therapy

    13C-UBT was used to determine whether Hp treatments was successful

Secondary outcomes

  1. side effects

    Time frame: assess at 2,4-6weeks after completion of the therapy

    such as diarrea,rash,dark stool

  2. changes of Shannon diversity indices for gut microbiome

    Time frame: assess at 0,2,4-6weeks after completion of the therapy

    changes of the Shannon diversity indices

  3. changes of OTU for gut microbiome

    Time frame: assess at 0,2,4-6weeks after completion of the therapy

    changes of OTU

  4. changes of abundances for gut microbiome

    Time frame: assess at ,2,4-6weeks after completion of the therapy

    changes of abundances of the bacteria

  5. CYP2C19 gene that impact the metabolism of PPI

    Time frame: detect the gene before the therapy

    CYP2C19 gene polymorphism

  6. virulence gene-cagA

    Time frame: detect the gene before the therapy

    cagA

  7. virulence gene-vacA

    Time frame: detect the gene before the therapy

    vacA

  8. patient compliance

    Time frame: assess compliance 2 weeks after the therapy

    good compliance is defined as taking more than 80% drugs

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhou, master

CONTACT

[email protected]

13917394900

Sponsors and collaborators

Lead sponsor

Ying HUANG

Other

Collaborators

  • Beijing Children's Hospital
  • Guangzhou Women and Children's Medical Center
  • Tang-Du Hospital
  • The Children's Hospital of Zhejiang University School of Medicine

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Dec 7, 2017
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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