Effect of Probiotics on Helicobacter Pylori Eradication

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 Helicobacter pylori quadruple eradication therapy and its influence on gastrointestinal flora.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Grand Biologic Pharmaceutical, Inc.
• Collaborators: 960th Hospital of People's Liberation Army; Fifth Affiliated Hospital of Zhengzhou University; Nanjing First Hospital, Nanjing Medical University; Renmin Hospital of Wuhan University; Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine; The First Affiliated Hospital of Nanchang University; The First Affiliated Hospital of Shanxi Medical University; The First People's Hospital of Yunnan; Xi'an Central Hospital; Zhejiang Provincial Hospital of TCM
• Treatments: Esomeprazole; Potassium Citrate

Criteria

Inclusion Criteria:

1. Voluntarily signing the informed consent form;

2. Aged 18-65 years old(including 65), male or female;

3. Patients aged 35-65 years old(including 35) with positive Helicobacter pylori should undergo gastroscopy, and the gastroscopy report shows normal or chronic gastritis;

4. 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 Criteria:

1. Gastroscopy report or previous medical history showed significant esophagus-gastric diseases, including gastric cancer, peptic ulcer, oesophagitis and esophageal erosion;

2. Patients with chronic diarrhea and chronic functional constipation;

3. 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;

4. Abnormal stool routine results: fecal occult blood (+) or white blood cells (+);

5. Patients with severe psychological or mental diseases;

6. Those with a history of drug abuse or alcohol abuse;

7. Those who are allergic to the drugs in this study;

8. Those who have received Helicobacter pylori eradication therapy;

9. 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.

10. Pregnant or lactating women;

11. Participating or after completing other clinical trials Less than 3 months;

12. Others who researchers consider unsuitable for inclusion.