Effect of Probiotics on Helicobacter Pylori Eradication

NCT04034641 | Unknown Phase 4

• 1 other identifier: HangzhouGrand
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

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

Conditions

Helicobacter Pylori Eradication

Outcome Measures

Primary Outcomes (1)

• the total incidence rate of digestive tract related adverse reactions

  The patient diary cards (including Bristol stool classification, diarrhea, constipation, abdominal pain, abdominal distension, belching, nausea, vomiting, loss of appetite and changes in taste) are filled in daily from the -14th day to 28th day. The above contents are recorded weekly from the 29th to182th day. to calculate the total incidence rate of digestive tract related adverse reactions mentioned above

  baseline, 28 days, 182days

Secondary Outcomes (7)

• the incidence rate of various digestive tract related symptoms

  baseline, 28 days, 182days

• duration of various digestive tract related symptoms

  baseline, 28 days, 182days

• stool frequency

  baseline, 28 days, 182days

• changes in intestinal flora

  baseline, 14 days, 28 days, 70 days, 182days

• changes in gastric flora

  baseline, 70 days

Study Arms (2)

probiotics plus standard therapy

EXPERIMENTAL

Drug: Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy

placebo plus standard therapy

PLACEBO COMPARATOR

Drug: Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy

Interventions

Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy DRUG

On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Probiotic: Bifidobacterium tetrad live bacteria tablets should be taken at noon once a day (30 min after meal ), 9 tablets per time. On day 15-28: Probiotic: Bifidobacterium tetrad live bacteria tablets, taken at noon once a day (30min after meal), 9 tablets per time.

probiotics plus standard therapy

Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy DRUG

On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Placebo: Bifidobacterium tetrad live bacteria tablet placebos should be taken at noon once a day ( 30 min after meal ), 9 tablets per time. On day 15-28: Placebo: Bifidobacterium tetrad live bacteria tablet placebos, taken at noon once a day (30min after meal), 9 tablets per time.

placebo plus standard therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Grand Biologic Pharmaceutical, Inc.: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• The First People's Hospital of Yunnan: collaborator
• Zhejiang Provincial Hospital of TCM: collaborator
• Fifth Affiliated Hospital of Zhengzhou University: collaborator
• Nanjing First Hospital, Nanjing Medical University: collaborator
• Xi'an Central Hospital: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Renmin Hospital of Wuhan University: collaborator

Study Sites (2)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Xi'an Central Hospital

Xi’an, Shanxi, China

RECRUITING

Study Officials

• Nonghua Lv, master

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Zhang, master

CONTACT

+8615901365519; zhanglu@hzydsw.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: June 17, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: December 4, 2019

Record last verified: 2019-07

Locations

CN (2)