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

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ClinicalTrials.gov Identifier: NCT03365609
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
Guangzhou Women and Children's Medical Center
The Children's Hospital of Zhejiang University School of Medicine
Beijing Children's Hospital
Tang-Du Hospital
Information provided by (Responsible Party):
Ying HUANG, Children's Hospital of Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Helicobacter Infections Drug: triple therapy Drug: sequential therapy Drug: bismuth quadruple therapy Drug: concomitant therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 13C-UBT [ Time Frame: 13C-UBT was assessed at 4-6 weeks after completion of therapy ]
    13C-UBT was used to determine whether Hp treatments was successful


Secondary Outcome Measures :
  1. side effects [ Time Frame: assess at 2,4-6weeks after completion of the therapy ]
    such as diarrea,rash,dark stool

  2. changes of Shannon diversity indices for gut microbiome [ Time Frame: assess at 0,2,4-6weeks after completion of the therapy ]
    changes of the Shannon diversity indices

  3. changes of OTU for gut microbiome [ Time Frame: assess at 0,2,4-6weeks after completion of the therapy ]
    changes of OTU

  4. changes of abundances for gut microbiome [ Time Frame: assess at ,2,4-6weeks after completion of the therapy ]
    changes of abundances of the bacteria

  5. CYP2C19 gene that impact the metabolism of PPI [ Time Frame: detect the gene before the therapy ]
    CYP2C19 gene polymorphism

  6. virulence gene-cagA [ Time Frame: detect the gene before the therapy ]
    cagA

  7. virulence gene-vacA [ Time Frame: detect the gene before the therapy ]
    vacA

  8. patient compliance [ Time Frame: assess compliance 2 weeks after the therapy ]
    good compliance is defined as taking more than 80% drugs


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365609


Contacts
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Contact: Ying Zhou, master 13917394900 nnyyhhs@163.com

Locations
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China, Shanghai
Children's hospital of Fudan university Recruiting
Shanghai, Shanghai, China, 201102
Contact: Ying Huang, MD and PhD    13816882247    yhuang815@163.com   
Sub-Investigator: Ying Zhou         
Sponsors and Collaborators
Ying HUANG
Guangzhou Women and Children's Medical Center
The Children's Hospital of Zhejiang University School of Medicine
Beijing Children's Hospital
Tang-Du Hospital
  Study Documents (Full-Text)

Documents provided by Ying HUANG, Children's Hospital of Fudan University:
Study Protocol  [PDF] October 1, 2017
Informed Consent Form  [PDF] October 1, 2017

More Information
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Publications:

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Responsible Party: Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03365609    
Other Study ID Numbers: HPT2017
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents