GastritisPhase 4NCT07139366
Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment
A Phase 4 study testing Bismuth, Esomeprazole and Tetracycline in people with Gastritis and Dyspepsia, run by Yongquan Shi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastritis, Dyspepsia, Helicobacter Pylori Infection
- What is being tested?
- Bismuth, Esomeprazole and Tetracycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,248 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to Sep 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032
Yongquan Shi, Ph. D, 86-29-84771515, shiyquan@fmmu.edu.cn
About this study
Official title: Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Bismuth, Esomeprazole, Tetracycline, Furazolidone, Saccharomyces Boulardii Oral Powder
- Medical subject headings
- Gastritis, Dyspepsia, Stomach Neoplasms, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BismuthDrug
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
EsomeprazoleDrug
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
TetracyclineDrug
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
FurazolidoneDrug
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 Oral PowderDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bismuth; Drug: Esomeprazole; Drug: Tetracycline; Drug: Furazolidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days after treatment
Secondary outcomes (1)
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.
Measured: 14 days of treatment, and 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start28 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongquan Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139366
- Sponsor's protocol ID
- KY20252348-F-1
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No