Status:
UNKNOWN
Effect of Probiotics on Helicobacter Pylori Eradication
Lead Sponsor:
Hangzhou Grand Biologic Pharmaceutical, Inc.
Collaborating Sponsors:
The First Affiliated Hospital of Nanchang University
The First People's Hospital of Yunnan
Conditions:
Helicobacter Pylori Eradication
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this clinical trial is to evaluate the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions of Helicob...
Detailed Description
Bismuth agent quadruple therapy (including bismuth agent and proton pump inhibitor combined with two antibiotics) is the first-line strategy to eradicate Helicobacter pylori in China. However, it may ...
Eligibility Criteria
Inclusion
- Voluntarily signing the informed consent form;
- Aged 18-65 years old(including 65), male or female;
- Patients aged 35-65 years old(including 35) with positive Helicobacter pylori should undergo gastroscopy, and the gastroscopy report shows normal or chronic gastritis;
- Patients aged 18-35 years (including 18) with positive Helicobacter pylori are not required to perform gastroscopy examination if there is no obvious clinical symptoms, or applying report of gastroscopy within 6 months showing normal or chronic gastritis.
Exclusion
- Gastroscopy report or previous medical history showed significant esophagus-gastric diseases, including gastric cancer, peptic ulcer, oesophagitis and esophageal erosion;
- Patients with chronic diarrhea and chronic functional constipation;
- Other systemic diseases, including cardiovascular diseases, lung diseases, liver diseases (transaminase index is more than 2 times higher than the normal value), kidney diseases (creatinine index is higher than the normal value) and other important organs with severe lesions, severe metabolic diseases (diabetes, thyroid diseases), malignant tumors, and severe immune system diseases;
- Abnormal stool routine results: fecal occult blood (+) or white blood cells (+);
- Patients with severe psychological or mental diseases;
- Those with a history of drug abuse or alcohol abuse;
- Those who are allergic to the drugs in this study;
- Those who have received Helicobacter pylori eradication therapy;
- Drugs which affect the intestinal flora(including antibacterial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used in the past 1 month or need to be used continuously for more than 1 week in the experiment.
- Pregnant or lactating women;
- Participating or after completing other clinical trials Less than 3 months;
- Others who researchers consider unsuitable for inclusion.
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04034641
Start Date
June 17 2019
End Date
December 31 2021
Last Update
December 4 2019
Active Locations (2)
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1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
2
Xi'an Central Hospital
Xi’an, Shanxi, China