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Recruiting NCT03365609

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

No phase Interventional Helicobacter Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: triple therapy, sequential therapy, bismuth quadruple therapy, concomitant therapy.
Who it may be relevant to
Registry conditions: Helicobacter Infections. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Detailed description

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.

Interventions

  • Drug triple therapy
    Omeprazole+Amoxicillin+Clarithromycin
  • Drug sequential therapy
    the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole
  • Drug bismuth quadruple therapy
    Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate
  • Drug concomitant therapy
    Omeprazole+Amoxicillin+Clarithromycin+Metronidazole

Primary outcome measures

  • 13C-UBT [Time frame: 13C-UBT was assessed at 4-6 weeks after completion of therapy]
Secondary outcome measures (8)
  • side effects [Time frame: assess at 2,4-6weeks after completion of the therapy]
  • changes of Shannon diversity indices for gut microbiome [Time frame: assess at 0,2,4-6weeks after completion of the therapy]
  • changes of OTU for gut microbiome [Time frame: assess at 0,2,4-6weeks after completion of the therapy]
  • changes of abundances for gut microbiome [Time frame: assess at ,2,4-6weeks after completion of the therapy]
  • CYP2C19 gene that impact the metabolism of PPI [Time frame: detect the gene before the therapy]
  • virulence gene-cagA [Time frame: detect the gene before the therapy]
  • virulence gene-vacA [Time frame: detect the gene before the therapy]
  • patient compliance [Time frame: assess compliance 2 weeks after the therapy]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Children's hospital of Fudan university — Shanghai

Publications

  • Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.000000 PMID 28541262

Identifiers

NCT: NCT03365609 · HPT2017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗