Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Summary

This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.

Conditions

• Gastritis
• Dyspepsia
• Helicobacter Pylori Infection
• Gastric Cancer
• Peptic Ulcer

Interventions

DRUG

Esomeprazole

High-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID plus amoxicillin 500 mg 2 capsules TID

DRUG

Amoxicillin

High-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 20mg 2 tablet TID

DRUG

Bismuth

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID

DRUG

Esomeprazole

BBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID

DRUG

Amoxicillin

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID

DRUG

Clarithromycin

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases

  lead OTHER

Principal Investigators

• Yongquan Shi, Ph. D · Xijing Hosipital of Digestive Disease

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2023-12-02

Completion

2024-03-10

Countries

• China

Study Locations