Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

NCT07139366 | Recruiting Phase 4

• 1 other identifier: KY20252348-F-1
• Study Type: interventional
• Target: 1,248
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating efficacy and safety of Saccharomyces boulardii combined with bismuth-containing quadruple Therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Saccharomyces boulardii combined with bismuth-containing quadruple Therapy is superior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication

  The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication

  28 days after treatment

Secondary Outcomes (1)

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (2)

Saccharomyces boulardii combined with Bismuth-containing quadruple therapy

EXPERIMENTAL

Saccharomyces boulardii powder 500 mg twice daily for 14 days#Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Drug: Bismuth; Drug: Esomeprazole; Drug: Tetracycline; Drug: Furazolidone; Drug: Saccharomyces Boulardii Oral Powder

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

Tetracycline 500mg three time daily for 14 days#furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Drug: Bismuth; Drug: Esomeprazole; Drug: Tetracycline; Drug: Furazolidone

Interventions

Bismuth DRUG

Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 1 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Bismuth-containing quadruple therapy; Saccharomyces boulardii combined with Bismuth-containing quadruple therapy

Esomeprazole DRUG

Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 20mg 1 tablets BID plus bismuth 110 mg 2 capsules BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Bismuth-containing quadruple therapy; Saccharomyces boulardii combined with Bismuth-containing quadruple therapy

Tetracycline DRUG

Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID#esomeprazole 20 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

Bismuth-containing quadruple therapy; Saccharomyces boulardii combined with Bismuth-containing quadruple therapy

Furazolidone DRUG

Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID#esomeprazole 20 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

Bismuth-containing quadruple therapy; Saccharomyces boulardii combined with Bismuth-containing quadruple therapy

Saccharomyces Boulardii Oral Powder DRUG

Saccharomyces boulardii combined with Bismuth-containing quadruple therapy:given for 14 days at a dose of Saccharomyces boulardii powder 250 mg 2 packets BID#bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 1 tablets BID#tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID

Saccharomyces boulardii combined with Bismuth-containing quadruple therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18\~75, both gender.
• Patients who had failed H.pylori eradication therapies .
• 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.

You may not qualify if:

• Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
• Contraindications to study drugs.
• Substantial organ impairment, 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).
• Pregnant or lactating women.
• Underwent upper gastrointestinal Surgery.
• Dysphagia.
• Evidence of bleeding or iron efficiency anemia.
• A history of malignancy.
• Drug or alcohol abuse history in the past 1 year.
• Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
• Mental disorder.
• Enrolled in other clinical trials in the past 3 months.
• Refuse to sign informed consent.

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Gastritis; Dyspepsia; Stomach Neoplasms; Peptic Ulcer

Interventions

Bismuth; Esomeprazole; Tetracycline; Furazolidone

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)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Furans

Central Study Contacts

Yongquan Shi

CONTACT

86-29-84771515; shiyquan@fmmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 24, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)