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

Helicobacter Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03365609
• Other study ID #: HPT2017
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Ying Zhou, master
• Phone: 13917394900
• Email: nnyyhhs[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections

Intervention

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

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Ying HUANG	Beijing Children's Hospital, Guangzhou Women and Children's Medical Center, Tang-Du Hospital, The Children's Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

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