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Study on the minimum antibiotic inhibitory concentration and mutation pattern of resistance gene for accurately predicting the eradication outcome of Helicobacter pylori by bismuth quadruple therapy

Study on the minimum antibiotic inhibitory concentration and mutation pattern of resistance gene for accurately predicting the eradication outcome of Helicobacter pylori by bismuth quadruple therapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300079073
Enrollment
Unknown
Registered
2023-12-25
Start date
2023-12-27
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Helicobacter pylori infection

Interventions

metronidazole-containing bismuth quadruple therapy:NA

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18 years old, =70 years old. (2) H. pylori infection (Confirmed by a positive 13C breath test). (3) Consistent with H. pylori eradication certification (according to the Fifth National Consensus Report on the Management of Helicobacter pylori Infection). (4) Gastroscopy should be performed according to clinical needs. (5) Patients who had previously received H. pylori eradication eradication failed and were allowed to be enrolled after 3 months of discontinuation. (6) Metronidazole has not been used in the eradication of H. pylori.

Exclusion criteria

Exclusion criteria: (1) Taking metronidazole for other purposes (such as oral therapy, gynecology, etc.) for <7 days before treatment. (2) Previous gastric surgery. (3) Pregnant and lactating women. (4) History of PPI, bismuth or antibiotic use in the last 4 weeks. (5) Patients with severe liver, kidney, heart dysfunction, malignant tumor, cerebrovascular disease. (6) Patients who have received H. pylori eradication therapy within 3 months prior to treatment, or who have taken antibiotics in the month prior to treatment (recent use of antibiotics prior to treatment may affect the efficacy of H. pylori eradication). (7) Patients allergic to the drugs used in the eradication programme.

Design outcomes

Primary

MeasureTime frame
The best MIC cut-off point to predict the eradication outcome of amoxicillin + Metronidazole bismuth quadruple therapy;

Secondary

MeasureTime frame
rdxA gene mutation combination pattern that can predict the eradication outcome of amoxicillin + metronidazole bismuth quadruple therapy;Eradication rate of standard bismuth quadruple therapy containing metronidazole (1200mg/ day);

Countries

China

Contacts

Public ContactSiyu Li

Beijing Hospital

lisiyu921024@163.com+86 188 1310 7814

Outcome results

None listed

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