Clinical trial NCT04956679: Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study
Official title: Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori
Family
Keywords: Helicobacter pylori
Family
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 400
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community population aged above 3 years in family unit,The family unit is determined by actual living together rather than household registration relationship, with at least 2 people in the family and living together for at least 10 months each year in the past 5 years.

Brief summary: The habit of family meals makes the infection rate of Helicobacter pylori high in China, which is also the main cause of reinfection of Helicobacter pylori. Eating together can easily cause family members to be infected with Helicobacter pylori. We used a real-world study to understand the risk factors, epidemiological characteristics, and safety and effectiveness of eradication therapy for helicobacter pylori infection in family-based screening and treatment.

Detailed description: Helicobacter pylori infection is a worldwide problem, which is the main cause of gastric cancer. The habit of sharing meals in the family is one of the factors contributing to the high infection rate of HP in China, as well as the main cause of reinfection of HP. Sharing meals can easily cause family members to be infected with HP.Family members live together, eat together, share tableware and other behaviors through the "mouth to mouth" transmission of Helicobacter pylori may be infected with each other, is also one of the reasons for the eradication of many patients after re-infection.At the same time, repeated infection and treatment of Helicobacter pylori will increase the difficulty of Helicobacter pylori reeradication.As a family unit, to study the status of our country family helicobacter pylori infection, epidemiological characteristics, infection risk factor, the different schemes, such as the safety and efficacy of treatment to take measures to reduce the infection rate is of great significance to prevention and treatment of gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Community population over 3 years old who signed the informed consent.
* at least 2 people in the family.
* living together for at least 10 months each year in the past 5 years except child aged below 5.

Exclusion Criteria:

* PPI drugs such as esomeprazole、pantoprazole、 rabeprazole,、lansoprazole、famotidine and H2 receptor antagonists were taken within two weeks.
* antibiotics、bismuth agents or traditional Chinese medicine with antibacterial effect were taken within four weeks
* There are other factors that researchers think are not suitable for participation

Primary outcomes:
measure: Patient compliance of performing medical examination.
timeFrame: 1 year
measure: Patient compliance of taking medication
timeFrame: 1 year
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 1 year
measure: Lesion detection ratio
timeFrame: 1 year
measure: Eradication rate
timeFrame: 1 year
Secondary outcomes:
measure: The high-risk factors of Helicobacter pylori infection in families were investigated by questionnaire statistics.
timeFrame: 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,QiLu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Li Yanqing, PhD
role: STUDY_CHAIR
References:
citation: Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.