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Application of String Test - qPCR Combined with 13C-Urea Breath Test in the Eradication Therapy of Helicobacter pylori Infection in the Tongliao Region

Application of String Test - qPCR Combined with 13C-Urea Breath Test in the Eradication Therapy of Helicobacter pylori Infection in the Tongliao Region

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108846
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-10
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Helicobacter pylori infection

Interventions

Experimental Group :Based on the antimicrobial susceptibility testing report, a personalized bismuth-containing quadruple therapy (PPI + Bismuth + two susceptible antibiotics) will be prescribed.
Control group :Empirical bismuth-based quadruple regimen (PPI + Bismuth + 2 antibiotics) will be initiated according to standard treatment guidelines and clinical judgment.
Observation group:None

Sponsors

The People's Hospital of Tongliao
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Part One, Epidemiological Investigation: The study subjects for this part will be the permanent resident population of the Tongliao region. 2. Part Two, Prospective, Randomized Controlled Trial: The inclusion criteria are: 1) Treatment-naïve patients with H. pylori infection, aged 18-80 years; 2) Those who provide informed consent and can tolerate the procedures involved in this study, including the string test, 13C-urea breath test, and the prescribed therapeutic regimen.

Exclusion criteria

Exclusion criteria: Part Two, Prospective, Randomized Controlled Trial: 1 Patients with severe cardiac, hepatic, or renal dysfunction, or psychiatric disorders; 2 Treatment-naïve patients who have taken antibiotics, proton pump inhibitors (PPIs), or related drugs within one month prior to enrollment; 3 Patients deemed ineligible to participate by the investigator's judgment; 4 Patients with a history of prior H. pylori eradication therapy or gastric surgery; 5 Patients with dysphagia who are unable to successfully swallow the string test capsule. Dysphagia will be rated using the Stooler scale: Grade 0 is eligible for enrollment; Grade 1 may be eligible after assessment; Grades 2, 3, and 4 will be excluded.

Design outcomes

Primary

MeasureTime frame
H. pylori eradiction rate;Consistency between string test-qPCR and 13C urea breath test;

Secondary

MeasureTime frame
Hp infection rate and epidemiological characteristics;

Countries

China

Contacts

Public ContactHuifang Pang

The People's Hospital of Tongliao

phf1986inner@163.com+86 152 4832 9866

Outcome results

None listed

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