Clinical trial NCT05438550: 14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection
Official title: 14-day High-dose Tegoprazan Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori Infection
High dose dual therapy
Bismuth-containing quadruple therapy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled study
Primary purpose: TREATMENT

Brief summary: The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomized to 14 days of dual therapy with Tegoprazan or 14 days of quadruple therapy with bismuth for eradication. At 6 weeks after treatment, subjects underwent another 13C-urea breath test. The eradication rate, adverse reaction rate and patient compliance were calculated.

Detailed description: 1. Informed consent: Patients with positive Helicobacter pylori were collected in the outpatient department, and the subjects receiving initial treatment signed informed consent.
2. Safety evaluation: C13 urea breath test, blood routine test, urine routine test, electrolyte test and liver and kidney function test were performed to confirm helicobacter pylori infection.
3. Confirm the inclusion of patients: fill in the case report form and enter group A or group B according to the randomization results.

   Group A: 14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan 50mg bid Amoxicillin 750mg qid Group B: 14-day bismuth-containing quadruple therapy (BQT) Esomeprazole 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid Potassium bismuth citrate 2g bid
4. Supervised medication: follow up the medication situation and adverse reactions by telephone 14 days after taking medication, and remind the reexamination 6 weeks after stopping medication.
5. Results: C13 urea breath test was repeated 6 weeks after drug withdrawal. Blood routine, urine routine, electrolytes and liver and kidney function tests were performed.
6. Complete the Case Report Form: Fill in the case report form accurately.
7. Data analysis: SPSS software was used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Helicobacter pylori infection (either positive for Helicobacter pylori culture, histopathological test, rapid urease test, C13/C14 urea breath test, or helicobacter pylori antigen test in feces).
* Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion Criteria:

* Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
* Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
* Active gastrointestinal bleeding.
* History of drug allergy.
* Medication history of bismuth, antibiotics and PPI within 4 weeks.
* Other behaviors that may increase the risk, such as alcohol and drug abuse.
* Unable or unwilling to provide informed consent.

Primary outcomes:
measure: Eradication rate
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Rate of adverse reactions
timeFrame: Immediately after the procedure
measure: Patient compliance
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo
role: PRINCIPAL_INVESTIGATOR
References: