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A Study on the Efficacy of Household-Based Helicobacter pylori Eradication Therapy

A Study on the Efficacy of Household-Based Helicobacter pylori Eradication Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084367
Enrollment
Unknown
Registered
2024-05-15
Start date
2024-05-15
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

helicobacter pylori infection

Interventions

intervention group:1.Collect survey questionnaires: Distribute household Hp related survey results. 2. Fecal Hp detection: Collect fecal samples from various family members, transport them to the cent
3.All H. pylori-positive household members received eradication therapy.
control group:To complete the questionnaire and to provide H. pylori eradication therapy only to the index patients.

Sponsors

The First Affiliated Hospital of Suzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.H. pylori-positive patients who voluntarily participate in this study. For family members not tested for H. pylori, they must commit to truthfully completing questionnaires and providing standard samples. 2.No use of antibiotics within the preceding 4 weeks, or Proton Pump Inhibitors (PPIs), Potassium-Competitive Acid Blockers (P-CABs), or H2-Receptor Antagonists (H2-RAs) within the preceding 2 weeks. 3.Voluntary provision of signed informed consent; aged 14 years or older (inclusive), both male and female. 4.Confirmed current H. pylori infection by any of the following methods: a positive result on 13C or 14C Urea Breath Test (13C-UBT or 14C-UBT) or stool antigen test (Note: DNA test is less common for active infection; Stool Antigen Test is standard). 5.Agreement to abstain from alcohol consumption during the medication period. 6.Agreement to have no pregnancy plans during the medication period and for at least 3 months after treatment cessation, and to voluntarily adopt effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1.Individuals with severe constipation or intestinal obstruction, rendering them unable to provide a stool sample. 2.Individuals presenting with any of the following alarm symptoms/signs: unexplained anemia, melena/hematemesis, anorexia, jaundice, or significant weight loss. 3.Individuals with severe hepatic or renal insufficiency, defined as: ALT or AST levels exceeding 2 times the upper limit of normal (ULN). Serum creatinine levels exceeding 1.5 times the ULN. A history of chronic alcoholism or alcohol abuse within 5 years prior to screening (defined as an average weekly intake of =14 units of alcohol; where 1 unit is equivalent to 285 mL of beer, 25 mL of spirits, or 100 mL of wine). 4.Individuals with dysphagia or pyloric obstruction. 5.Individuals with clinically significant electrocardiogram (ECG) abnormalities. 6.Individuals with a history of hypersensitivity to multiple drugs. 7.Individuals with a white blood cell count or neutrophil count below the lower limit of normal. 8.Individuals who are planning pregnancy (both male and female), are currently pregnant, or are lactating. 9.Individuals with any other conditions (e.g., multiple drug allergies) deemed by the investigator as unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Household-based eradication rate;

Countries

China

Contacts

Public ContactFeng Huang

The First Affiliated Hospital of Suzhou University

nancyfh@163.com+86 158 5016 5709

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026