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Идёт набор NCT03365609

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

Без фазы С лечением Helicobacter Infections

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: triple therapy, sequential therapy, bismuth quadruple therapy, concomitant therapy.
Кому может быть актуально
Состояния в реестре: Helicobacter Infections. Базовые параметры: 6 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • 13C-UBT [Срок оценки: 13C-UBT was assessed at 4-6 weeks after completion of therapy]
Вторичные конечные точки (8)
  • side effects [Срок оценки: assess at 2,4-6weeks after completion of the therapy]
  • changes of Shannon diversity indices for gut microbiome [Срок оценки: assess at 0,2,4-6weeks after completion of the therapy]
  • changes of OTU for gut microbiome [Срок оценки: assess at 0,2,4-6weeks after completion of the therapy]
  • changes of abundances for gut microbiome [Срок оценки: assess at ,2,4-6weeks after completion of the therapy]
  • CYP2C19 gene that impact the metabolism of PPI [Срок оценки: detect the gene before the therapy]
  • virulence gene-cagA [Срок оценки: detect the gene before the therapy]
  • virulence gene-vacA [Срок оценки: detect the gene before the therapy]
  • patient compliance [Срок оценки: assess compliance 2 weeks after the therapy]

Критерии участия

Критерии включения

  • children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Children's hospital of Fudan university — Шанхай

Публикации

  • 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.000000 PMID 28541262

Идентификаторы

NCT: NCT03365609 · HPT2017

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗