helicobacter pylori infection
Conditions
Interventions
A:placebo Bid for 14 days and placebo Bid + standard triple therapy for another 14 days
B:Pylopass TM 400mg Bid for 14 days and Pylopass TM 400mg Bid + standard triple therapy for another 14 days
Sponsors
Nanfang Hospital Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 70 years male and female; 2) Voluntary signing of written informed consent with good compliance; 3) Gastritis or asymptomatic subjects with Helicobacter Pylori infection diagnosed by 13C-UBT; 4) Subjects with fertility are required to receive effective medical contraceptives (Whether male or female subjects, from the signing of informed consent form to 30 days after the last study administration).
Exclusion criteria
Exclusion criteria: 1) Subjects who have been treated with HP in the past; 2) Those who took antibiotics, proton pump inhibitors, H2 receptor antagonists, bismuth agents and some traditional Chinese medicines with antibacterial effects 4 weeks before the entry; 3) Previous history of digestive system surgery (except appendectomy, polyp resection and gallbladder resection); 4) Gastroscopy revealed complications such as bleeding, pylorus obstruction, perforation, gastrointestinal tumors, and so on; 5) Contraindications with PPIs, amoxicillin and clarithromycin; 6) Subjects who need to take non-steroidal anti-inflammatory drugs (Nsaids) and aspirin continuously during the trial period or within 2 weeks before entering the group; 7) Severe or unstable cardiovascular, pulmonary or endocrine diseases, kidney or liver diseases of clinical significance, blood system diseases, any other diseases of clinical significance, or diseases judged by the researchers to increase the risk of the subjects in this study; 8) Any malignant diseases except for skin cancer with successful treatment (basal or squamous cell carcinoma) or high-grade abnormal Barrette esophagus in the past five years; 9) Subjects with a history of infection with human immunodeficiency virus, or with other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 10) Subjects with severe mental or nervous system abnormalities; 11) Those who are pregnant or lactating before joining the group; 12) Drug addicts, alcoholics and drug abusers within one year before joining the group; 13) Subjects unable to insist on treatment and participating in other clinical trials; 14) Subjects whoare known or suspected to be allergic to drugs used in this trial; 15) Those who participated in other clinical trials within 4 weeks before admission to the group; 16) Subjects who are judged to be poor of compliance and considered unsuitable to participate in the clinical trial; 17) Related personnel in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| UBT value;symptom remission rate;the rate of side effects;Quality of Life; | — |
Countries
China
Contacts
Public ContactYe Chen
GI Department Nanfang Hospital Southern Medical University
Outcome results
None listed