Completed

Helicobacter Pylori Eradication Clostridium Butyricum Capsule and Bacillus Coagulans Tablets With Hydrochloride,Esomeprazole,Amoxicillin and Bismuth-containing Quadruple Therapy: a Randomized,Single-center，Open-label,Phase Ⅳ Trail

What is being tested

Clostridium butyricum capsule

+ esomeprazole

+ amoxicillin

Drug

Who is being recruted

Digestive System Diseases+9

+ Duodenal Diseases

+ Dyspepsia

From 18 to 75 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: May 2020

See protocol details

Summary

Principal SponsorXijing Hospital of Digestive Diseases

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 5, 2020

Actual date on which the first participant was enrolled.

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Urea Breath test will be performed in addition to the baseline routine evaluations. Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14. Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Official TitleHelicobacter Pylori Eradication Clostridium Butyricum Capsule and Bacillus Coagulans Tablets With Hydrochloride,Esomeprazole,Amoxicillin and Bismuth-containing Quadruple Therapy: a Randomized,Single-center，Open-label,Phase Ⅳ Trail

NCT05237115

Principal SponsorXijing Hospital of Digestive Diseases

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDuodenal DiseasesDyspepsiaGastritisGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPeptic UlcerSigns and SymptomsSigns and Symptoms, DigestiveStomach DiseasesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate

Age between 18~75,both gender.

Patients with upper gastrointestinal symptoms and with documented H.pylori infection.

Patients are willing to receive eradication treatment.

Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

15 exclusion criteria prevent from participating

Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.

contraindications or allergies to research drugs.

Substantial organ impairment(eg liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease.

Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

given for 14 days at a dose of Clostridium butyricum capsule 420mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Group II

Experimental

given for 14 days at a dose of Bacillus coagulans tablets 350mg 3 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Group III

Active Comparator

given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 40 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Xijing Hospital of Digestive Diseases

Xi’an, ChinaOpen Xijing Hospital of Digestive Diseases in Google Maps

CompletedOne Study Center