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

NCT03365609 | Recruiting

• 1 other identifier: HPT2017
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• side effects

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

• changes of Shannon diversity indices for gut microbiome

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

• changes of OTU for gut microbiome

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

• changes of abundances for gut microbiome

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

• CYP2C19 gene that impact the metabolism of PPI

  detect the gene before the therapy

Study Arms (4)

T-group

EXPERIMENTAL

T-group(triple therapy)

Drug: triple therapy

S-group

EXPERIMENTAL

S-group( sequential therapy)

Drug: sequential therapy

B-group

EXPERIMENTAL

B-group( bismuth quadruple therapy )

Drug: bismuth quadruple therapy

C-group

EXPERIMENTAL

C-group( concomitant therapy)

Drug: concomitant therapy

Interventions

triple therapy DRUG

Omeprazole+Amoxicillin+Clarithromycin

T-group

sequential therapy DRUG

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

S-group

bismuth quadruple therapy DRUG

Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate

B-group

concomitant therapy DRUG

Omeprazole+Amoxicillin+Clarithromycin+Metronidazole

C-group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 28541262 BACKGROUND

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Ying Zhou, master

CONTACT

13917394900; nnyyhhs@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of gastroenterology of Children's Hospital of Fudan

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 7, 2017
• Study Start: September 20, 2017
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)