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

NCT05742568 | Completed Phase 4

• 1 other identifier: KY20222310-C-1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Helicobacter pylori; High-dose dual therapy; Bismuth-combining quadruple therapy; Intestinal Microecology

Outcome Measures

Primary Outcomes (1)

• Changes in the diversity and structure of fecal microbiota

  Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens.

  before treatment,1day after treatment,6 weeks after treatment

Secondary Outcomes (1)

• Eradication rate of Helicobacter pylori

  28 days after treatment

Study Arms (2)

High-dose dual therapy

EXPERIMENTAL

Esomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks.

Drug: Esomeprazole; Drug: Amoxicillin

Bismuth Quadruple Therapy

ACTIVE COMPARATOR

Esomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks.

Drug: Bismuth; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin

Interventions

Esomeprazole DRUG

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

Also known as: Nexium

High-dose dual therapy

Bismuth DRUG

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

Bismuth Quadruple Therapy

Amoxicillin DRUG

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

Also known as: Amoxy

High-dose dual therapy

Clarithromycin DRUG

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

Bismuth Quadruple Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years, regardless of gender.
• Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy.
• Voluntary Hp eradication therapy.
• Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends.

You may not qualify if:

• Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy.
• Patients with contraindications to or allergies to the study drug.
• Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease
• Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection)
• Pregnant and lactating women.
• Having undergone upper gastrointestinal surgery.
• Have symptoms of dysphagia.
• Evidence of bleeding or iron deficiency anemia.
• History of malignancy.
• History of drug or alcohol abuse within the last 1 year.
• Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100 mg/d)
• Those with psychiatric disorders.
• Received other clinical trials within the past 3 months
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Gastritis; Dyspepsia; Stomach Neoplasms; Peptic Ulcer

Interventions

Esomeprazole; Amoxicillin; Bismuth; Clarithromycin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Yongquan Shi, Ph. D

  Xijing Hosipital of Digestive Disease

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 24, 2023
• Study Start: December 1, 2022
• Primary Completion: December 2, 2023
• Study Completion: March 10, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)