Clinical trial NCT05901051: High-dose Dual Therapy with Different Administration Frequencies
Official title: Randomized and Controlled Clinical Study of High-dose Dual Therapy with Different Administration Frequencies in the Treatment of Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Dual Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Detailed description: According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.

Eligibility criteria: Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection

Exclusion Criteria:

* Pregnant and lactating women;
* History of gastrointestinal malignancies;
* History of previous subtotal gastrectomy;
* Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
* History of hematological diseases
* People who are allergic to drugs;
* The guardian or patient refused to join the group;
* Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
* No legal capacity or poor self-knowledge
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse events
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References: