Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study

NCT04956679 | Unknown DMC

• 1 other identifier: 2019SDU-QILU-186
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori; Family

Keywords

Helicobacter pylori; Family

Outcome Measures

Primary Outcomes (5)

• Patient compliance of performing medical examination.

  Good compliance of medical examination advice was defined as the subjects took the medical advice given by the doctor and the rate of adoption and implementation of the medical examination advice.

  1 year

• Patient compliance of taking medication

  Patient compliance of taking medication is defined as the ratio of the actual dose of medication taken by the patient to the total amount of medication required by the prescription. Good medication compliance is defined as the ratio greater than 80%.

  1 year

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Adverse reactions related to medication were recorded

  1 year

• Lesion detection ratio

  The lesion detection ratio was defined as the ratio of the number of subjects who underwent medical examination on the basis of doctor's recommendation and were finally diagnosed with lesion to the number of subjects who underwent examination.

  1 year

• Eradication rate

  Eradication rate was defined as the ratio of the number of patients diagnosed positive on the carbon 13 breath test to the number of subjects who turned negative after taking the eradication drug to the number of subjects diagnosed positive before taking the drug.

  1 year

Secondary Outcomes (1)

• The high-risk factors of Helicobacter pylori infection in families were investigated by questionnaire statistics.

  1 year

Study Arms (1)

Family members in the study

Community groups that meet the inclusion criteria

Diagnostic Test: carbon 13 breath test

Interventions

carbon 13 breath test DIAGNOSTIC_TEST

Patients with positive Helicobacter pylori infection were determined by carbon 13 breath test ,The diagnosis and treatment of positive patients were followed up without other intervention.

Family members in the study

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology,QiLu Hospital,Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33004546 BACKGROUND

Study Officials

• Li Yanqing, PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Li Yanqing, PhD

CONTACT

053182169385; liyanqing@sdu.edu.cn

Li Yueyue, PhD

CONTACT

18560089751; lyynqj@126.com

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of QiLu Hospital

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 9, 2021
• Study Start: July 10, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

CN (1)