A Phase 4 interventional study of Bismuth and Esomeprazole in Gastritis, Dyspepsia and Helicobacter Pylori Infection, sponsored by Yongquan Shi. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Yongquan Shi · Phase 4, Interventional, and Treatment
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.
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen 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 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.
Exclusion Criteria:
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
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
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: 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: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: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
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
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
Time frame: 28 days after treatment
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.
Time frame: 14 days of treatment, and 28 days after treatment
Plan to share: No
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Yongquan Shi