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| Name | Class |
|---|---|
| Guangzhou Women and Children's Medical Center | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Beijing Children's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-group | Experimental | T-group(triple therapy) |
|
| S-group | Experimental | S-group( sequential therapy) |
|
| B-group | Experimental | B-group( bismuth quadruple therapy ) |
|
| C-group | Experimental | C-group( concomitant therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple therapy | Drug | Omeprazole+Amoxicillin+Clarithromycin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| side effects | such as diarrea,rash,dark stool | assess at 2,4-6weeks after completion of the therapy |
| changes of Shannon diversity indices for gut microbiome | changes of the Shannon diversity indices |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhou, master | Contact | 13917394900 | nnyyhhs@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital of Fudan university | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28541262 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2017 | Dec 1, 2017 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2017 | Dec 1, 2017 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016481 | Helicobacter Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Tang-Du Hospital |
| OTHER |
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| sequential therapy |
| Drug |
the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole |
|
| bismuth quadruple therapy | Drug | Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate |
|
| concomitant therapy | Drug | Omeprazole+Amoxicillin+Clarithromycin+Metronidazole |
|
| assess at 0,2,4-6weeks after completion of the therapy |
| changes of OTU for gut microbiome | changes of OTU | assess at 0,2,4-6weeks after completion of the therapy |
| changes of abundances for gut microbiome | changes of abundances of the bacteria | assess at ,2,4-6weeks after completion of the therapy |
| CYP2C19 gene that impact the metabolism of PPI | CYP2C19 gene polymorphism | detect the gene before the therapy |
| virulence gene-cagA | cagA | detect the gene before the therapy |
| virulence gene-vacA | vacA | detect the gene before the therapy |
| patient compliance | good compliance is defined as taking more than 80% drugs | assess compliance 2 weeks after the therapy |