A Comparison of Four Different Treatment Regimens of 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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Infections
• Intervention / Treatment: Drug: triple therapy; Drug: sequential therapy; Drug: bismuth quadruple therapy; Drug: concomitant therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Zhou, master; Phone Number: 13917394900; Email: nnyyhhs@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Ying Huang, MD and PhD; Phone Number: 13816882247; Email: yhuang815@163.com
      • Sub-Investigator: Ying Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-group; T-group(triple therapy)	Drug: triple therapy; Omeprazole+Amoxicillin+Clarithromycin
Experimental: S-group; S-group( sequential therapy)	Drug: sequential therapy; the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole
Experimental: B-group; B-group( bismuth quadruple therapy )	Drug: bismuth quadruple therapy; Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate
Experimental: C-group; C-group( concomitant therapy)	Drug: concomitant therapy; Omeprazole+Amoxicillin+Clarithromycin+Metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
13C-UBT	13C-UBT was used to determine whether Hp treatments was successful	13C-UBT was assessed at 4-6 weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	such as diarrea,rash,dark stool	assess at 2,4-6weeks after completion of the therapy
changes of Shannon diversity indices for gut microbiome	changes of the Shannon diversity indices	assess at 0,2,4-6weeks after completion of the therapy
changes of OTU for gut microbiome	changes of OTU	assess at 0,2,4-6weeks after completion of the therapy
changes of abundances for gut microbiome	changes of abundances of the bacteria	assess at ,2,4-6weeks after completion of the therapy
CYP2C19 gene that impact the metabolism of PPI	CYP2C19 gene polymorphism	detect the gene before the therapy
virulence gene-cagA	cagA	detect the gene before the therapy
virulence gene-vacA	vacA	detect the gene before the therapy
patient compliance	good compliance is defined as taking more than 80% drugs	assess compliance 2 weeks after the therapy

Collaborators and Investigators

• Sponsor: Ying HUANG
• Collaborators: Tang-Du Hospital; Beijing Children's Hospital; Guangzhou Women and Children's Medical Center; The Children's Hospital of Zhejiang University School of Medicine

Publications and helpful links

General 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.0000000000001594.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: HPT2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No