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Efficacy and Safety of Doxycycline-Based Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients

Efficacy and Safety of Doxycycline-Based Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116496
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-01-27

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 A (dual therapy group):Vonoprazan + Doxycycline
Experimental group B (triple therapy group):Vonoprazan + Doxycycline + Bismuth Potassium Citrate
Control group (quadruple therapy group):Vonoprazan + Doxycycline + Bismuth Potassium Citrate + Metronidazole

Sponsors

The Second People's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, regardless of gender; 2. Has a history of penicillin allergy or a positive penicillin skin test; 3. No use of antibiotics, bismuth agents, PPIs, or P-CABs within the past four weeks; 4. Positive 13C-urea breath test or gastroscopy-confirmed Helicobacter pylori infection; 5. Naive patients who agree to undergo H. pylori eradication therapy and are willing to cooperate with follow-up surveys on eradication efficacy.

Exclusion criteria

Exclusion criteria: 1. Individuals with severe impairment of cardiac, hepatic, or renal function; 2. Pregnant or lactating women; 3. History of previous *Helicobacter pylori* eradication therapy, upper gastrointestinal surgery, gastric malignancy, hepatic or renal impairment, pyloric stenosis, or pregnancy; 4. Participation in any other drug clinical trial within the 3 months prior to taking the study medication; 5. Concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs) or a history of alcohol abuse; 6. Known allergy to any of the drugs used in the trial.

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
Adverse events;Compliance;

Countries

China

Contacts

Public ContactXiaoyong Wang

The Second People's Hospital of Changzhou, the Third Affiliated Hospital of Nanjing Medical University

wxy20009@126.com+86 137 7505 1593

Outcome results

None listed

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