Influencing Factors of Helicobacter Pylori Infection and Eradication Failure
6 de febrero de 2022 actualizado por: Second Affiliated Hospital of Xi'an Jiaotong University
Analysis of Influencing Factors of Helicobacter Pylori Infection and Eradication Failure in Outpatients of Digestive Department in Xi'an
Helicobacter pylori (H.
pylori) is closely related to the occurrence of gastric cancer and other diseases, the discovery and eradication of H. pylori infection has great significance to the prevention and treatment of related diseases.
At the same time,understanding the influencing factors of H. pylori infection and eradication failure in the population can provide a scientific basis for the formulation of local H. pylori prevention and control strategies.
So, the investigators intend to analyze the factors related to H. pylori infection and eradication failure in the outpatients of gastroenterology clinics in Xi'an, China.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Taking 300 permanent residents in Xi'an area who will go to the Gastroenterology Clinic of the Second Affiliated Hospital of Xi'an Jiaotong University from February 2022 to March 2023 and undergo 13C-UBT examination as the research object.
A questionnaire survey on factors related to H. pylori infection and eradication failure will be conducted.
The questionnaire includes basic Information, eating patterns, living environment, related gastrointestinal symptoms, etc.
Among the outpatients, H. pylori-positive patients will be given rabeprazole 10 mg + amoxicillin 1000 mg + clarithromycin 500 mg + colloidal bismuth tartrate 220 mg bid for 14 days.
After 4-6 weeks of completing eradication therapy, 13C-UBT will be performed to determine whether H. pylori is eradicated.
According to the results of 13C-UBT at the beginning and results of 13C-UBT after eradication treatment, outpatients will be divided into three groups: H. pylori negative group, H. pylori positive radical cure successful group and H. pylori positive radical cure failed group.
Next using SPSS 19.0 Statistical software analyzes H. pylori infection and eradication failure related influencing factors.
According to the analysis, the investigators can provide a scientific basis for local formulation of correct and effective H. pylori prevention and control strategies.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
300
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Shi Cheng, MD
- Correo electrónico: 826326535@qq.com
Ubicaciones de estudio
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710004
- Reclutamiento
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Contacto:
- Ping Zhao, MD
- Correo electrónico: peggyzhao@163.com
-
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Perform 13-UBT,
- Be able to understand the content of the questionnaire and answer the questions accurately,
- Permanent residents of Xi'an area,
- No previous HP eradication treatment,
- Agree to join the group and sign the informed consent form,
- Aged between 18-70.
Exclusion Criteria:
- Complicated with serious cardiovascular, respiratory, blood, liver, kidney, nerve or endocrine system diseases,
- Mental disease,
- Gastric or esophageal surgery history,
- Severe atypical hyperplasia of gastric epithelium, gastric malignant tumor or other malignant diseases
- Pregnant or lactating women,
- Patients with history of penicillin allergy,
- Allergy to rabeprazole, bismuth dose, clindamycin,
- Have taken proton pump inhibitors,H2 receptor antagonists, within 2 weeks before participating in the inspection,
- Have taken herbs that have bacteriostatic effect or antibiotic or bismuth agents within 4 weeks before participating in the inspection.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: H. pylori negative group
No Intervention
|
|
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Otro: H. pylori positive and successful eradication group
H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days.
After 4-6 weeks of completing eradication therapy, 13C-UBT is performed and the result show that H. pylori is eradicated.
At the same time, Patients with successful eradication are instructed to conduct 13C-UBT examination after 6 months,1year and every year after drug withdrawal.
|
Among these outpatients, H. pylori-negative patients don't give any intervention.
But H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days.
After 4-6 weeks of completing eradication therapy, 13C-UBT is performed.
|
|
Otro: H. pylori positive and eradication failure group
H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days.
After 4-6 weeks of completing eradication therapy, 13C-UBT is performed and the result show that H. pylori is not eradicated.
|
Among these outpatients, H. pylori-negative patients don't give any intervention.
But H. pylori-positive patients are given rabeprazole 10mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth tartrate 220mg bid for 14 days.
After 4-6 weeks of completing eradication therapy, 13C-UBT is performed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Infection rate
Periodo de tiempo: 1 year
|
The infection rate is defined as the proportion of patients diagnosed positive among all subjects undergoing 13-UBT.(On the 13-UBT,if the result DOB≥4.
0‰, it can be determined that the subject is H. pylori positive; DOB <4.
0‰,the subject is H. pylori negative)
|
1 year
|
|
The Affecting factors of Helicobacter pylori infection is investigated by questionnaire statistics.
Periodo de tiempo: 1 year
|
The questionnaire refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between Helicobacter pylori infection and the factors involved in the questionnaire.
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1 year
|
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Eradication rate
Periodo de tiempo: 1 year
|
H. pylori-positive patients are given PPI quadruple therapy,and after 4-6 weeks of completing eradication therapy, 13C-UBT is performed.Eradication rate is defined as the ratio of the number of subjects who become negative after taking the eradication drug to the number of all subjects who take the eradication drug.
|
1 year
|
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The Affecting factors of Helicobacter pylori eradication failure is investigated by questionnaire statistics.
Periodo de tiempo: 1 year
|
The questionnaire refers to "National Helicobacter pylori Research Questionnaire", which is designed by the Department of Epidemiology and Health Statistics, Peking University School of Medicine.And the questionnaire includes general situation, basic situation, living environment and living habits, personal disease history, related symptoms,and family history, etc.Through logistic regression analysis to calculate OR value and P value, to understand the relationship between Helicobacter pylori eradication failure and the factors involved in the questionnaire.
|
1 year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de febrero de 2022
Finalización primaria (Anticipado)
1 de septiembre de 2022
Finalización del estudio (Anticipado)
1 de marzo de 2023
Fechas de registro del estudio
Enviado por primera vez
8 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
3 de febrero de 2022
Publicado por primera vez (Actual)
7 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
6 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020065
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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