Effect of Probiotics on Helicobacter Pylori Eradication

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

Interventions

DRUG

Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy

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.

DRUG

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

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Zhejiang Provincial Hospital of TCM

  collaborator OTHER

• Fifth Affiliated Hospital of Zhengzhou University

  collaborator UNKNOWN

• Nanjing First Hospital, Nanjing Medical University

  collaborator OTHER

• Xi'an Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Hangzhou Grand Biologic Pharmaceutical, Inc.

  lead INDUSTRY

Principal Investigators

• Nonghua Lv, master · The First Affiliated Hospital of Nanchang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-17

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• China

Study Locations