An interventional study of triple therapy and sequential therapy in Helicobacter Infections, sponsored by Ying HUANG. Recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Ying HUANG · Not applicable, Interventional, and Treatment
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.
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.
188 studies on the registry are indexed under Helicobacter Infections; 33 are open to participants now.
This study's planned enrollment of 1,440 is above the median of 160 across 134 interventional studies indexed under Helicobacter Infections.
Browse Helicobacter Infections studies →This is the only study on the registry with Ying HUANG as lead sponsor.
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Exclusion Criteria:
T-group(triple therapy)
Drug: triple therapy
S-group( sequential therapy)
Drug: sequential therapy
B-group( bismuth quadruple therapy )
Drug: bismuth quadruple therapy
C-group( concomitant therapy)
Drug: concomitant therapy
Omeprazole+Amoxicillin+Clarithromycin
the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole
Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate
Omeprazole+Amoxicillin+Clarithromycin+Metronidazole
13C-UBT
13C-UBT was used to determine whether Hp treatments was successful
Time frame: 13C-UBT was assessed at 4-6 weeks after completion of therapy
side effects
such as diarrea,rash,dark stool
Time frame: assess at 2,4-6weeks after completion of the therapy
changes of Shannon diversity indices for gut microbiome
changes of the Shannon diversity indices
Time frame: assess at 0,2,4-6weeks after completion of the therapy
changes of OTU for gut microbiome
changes of OTU
Time frame: assess at 0,2,4-6weeks after completion of the therapy
changes of abundances for gut microbiome
changes of abundances of the bacteria
Time frame: assess at ,2,4-6weeks after completion of the therapy
CYP2C19 gene that impact the metabolism of PPI
CYP2C19 gene polymorphism
Time frame: detect the gene before the therapy
virulence gene-cagA
cagA
Time frame: detect the gene before the therapy
virulence gene-vacA
vacA
Time frame: detect the gene before the therapy
patient compliance
good compliance is defined as taking more than 80% drugs
Time frame: assess compliance 2 weeks after the therapy
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Plan to share: No
Started Sep 2017 (actual). Primary completion is estimated for Oct 2025, 96 months after the start.
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