Clinical trial NCT03365609: A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Helicobacter Infections
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Guangzhou Women and Children's Medical Center
name: The Children's Hospital of Zhejiang University School of Medicine
name: Beijing Children's Hospital
name: Tang-Du Hospital
First posted: 2017-12-07
Enrollment: 1440
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: 13C-UBT
timeFrame: 13C-UBT was assessed at 4-6 weeks after completion of therapy
Secondary outcomes:
measure: side effects
timeFrame: assess at 2,4-6weeks after completion of the therapy
measure: changes of Shannon diversity indices for gut microbiome
timeFrame: assess at 0,2,4-6weeks after completion of the therapy
measure: changes of OTU for gut microbiome
timeFrame: assess at 0,2,4-6weeks after completion of the therapy
measure: changes of abundances for gut microbiome
timeFrame: assess at ,2,4-6weeks after completion of the therapy
measure: CYP2C19 gene that impact the metabolism of PPI
timeFrame: detect the gene before the therapy
measure: virulence gene-cagA
timeFrame: detect the gene before the therapy
measure: virulence gene-vacA
timeFrame: detect the gene before the therapy
measure: patient compliance
timeFrame: assess compliance 2 weeks after the therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
References:
citation: 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.