Helicobacter Pylori infection
Conditions
Sponsors
The 1st Affiliated Hospital of He'nan University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 ) Sign the informed consent before the test, and fully understand the test content, process and possible adverse reactions ; 2 ) can complete the research according to the requirements of the test plan ; 3 ) Subjects ( including male subjects ' partners ) had no fertility plan and voluntarily took effective contraceptive measures from 14 days before screening to 6 months after the end of the trial ; 4 ) Male and female subjects aged 18-65 years ( including 18 and 65 years ) ; 5 ) Male subjects weighing no less than 50 kg. Female subjects weighing no less than 45 kg. Body mass index ( BMI ) = weight ( kg ) / height 2 ( m2 ), BMI = 19.0 kg / m2 ; 6 ) Chinese adults who met one of the three diagnostic criteria in the ' 2019 Guidelines for the Diagnosis and Treatment of Helicobacter Pylori Infection at the Grassroots Level ' : 1 ) RUT, tissue section staining or bacterial culture of gastric mucosa were positive for any of the three ; 2 ) 13C or 14C-UBT positive ; 3 ) HpSA test positive. The positive detection of serum Hp antibody indicates that the patient has been infected and has never been treated can be regarded as a current infection. 7 ) without heart, liver, kidney, nervous system, mental disorders and metabolic abnormalities. Those who meet all the above conditions can be selected.
Exclusion criteria
Exclusion criteria: 1 ) Allergic constitution, or allergic to any component of the drug ; 2 ) Have a history of alcohol abuse ( drinking more than 14 units of alcohol per week : 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine ) ; 3 ) Blood donation or massive blood loss ( = 200 mL ) within 3 months before taking the test drug ; 4 ) Gastroscopy report or past medical history showed obvious gastroesophageal diseases, including gastric cancer, esophagitis, esophageal erosion ; 5 ) patients with chronic diarrhea and chronic functional constipation ; 6 ) Other systemic diseases, including cardiovascular disease, lung disease, liver disease ( transaminase index > 2.5 times the normal value ), kidney disease ( creatinine index higher than the normal value ) and other important organ serious lesions, severe metabolic diseases ( diabetes, thyroid disease ), malignant tumor, severe immune system disease ; 7 ) Stool routine abnormalities : fecal occult blood ( + ) or white blood cells ( + ) ; 8 ) participated in other drug clinical trials within 3 months before taking the test drug ; 9 ) The abnormal clinical significance was judged by the researchers, including physical examination, vital signs examination and clinical laboratory examination. 10 ) patients with serious mental illness ; 11 ) Patients who received Helicobacter pylori eradication therapy ; 12 ) Drug abuse screening positive or had a history of drug abuse in the past 5 years or had used drugs within 3 months before the test ; 13 ) Screening the average daily smoking amount = 5 cigarettes in the first 3 months ; 14 ) Female subjects are in the lactation period or blood / urine pregnancy test results are positive during the screening period or during the test ; 15 ) drugs that affect the intestinal flora ( including antibiotics, probiotics, intestinal mucosal protective agents, Chinese patent medicine, etc. ) were continuously used for more than 1 week within 1 month before screening ; ( 16 ) HIV positive or acquired immunodeficiency syndrome ( AIDS ) history ; patients with hepatitis B HbsAg positive or hepatitis C virus infection ; 17 ) those who were vaccinated within 3 months before taking the study drug or planned to be vaccinated during the trial ; 18 ) underwent surgery within 3 months before the first administration ( except diagnostic biopsy ) ; 19 ) stop taking the test sample or take other drugs halfway, unable to judge the efficacy or incomplete data ; 20 ) Taking items with similar functions to the subjects in the short term affects the judgment of the results ; 21 ) subjects who cannot participate in the experiment for their own reasons ; 22 ) Other researchers determined subjects who were not suitable for participation. Those who meet any of the above conditions shall not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HP eradication rate;GRSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| SBMs;BFSF;intestinal flora sequencing;serological indicators; | — |
Countries
China
Contacts
Public ContactZhang Yingjian
first affiliated hospital of He'nan University of Science and Technology
Outcome results
None listed