Skip to content

Effect of BIFICO combined with bismuth quadruple therapy containing amoxicillin and furazolidone on gastrointestinal microbiota in patients with refractory Helicobacter pylori infection

Effect of BIFICO combined with bismuth quadruple therapy containing amoxicillin and furazolidone on gastrointestinal microbiota in patients with refractory Helicobacter pylori infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023008
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-05-10
Completion date
Unknown
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

helicobacter pylori infection

Interventions

Group A:BIFICO t.i.d for 30 days + esomeprazole b.i.d + bismuth potassium citrate b.i.d + amoxicillin b.i.d + furazolidone b.i.d for 14 days
Group B:esomeprazole b.i.d + bismuth potassium citrate b.i.d + amoxicillin b.i.d + furazolidone b.i.d for 14 days

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 or older, female and male; 2. Patients who failed to eradicate Hp = 2 times; 3. After 3-6 months of eradication failure, the 13C breath test was positive and confirmed as Hp persistent infection; 4. Voluntarily participate in and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of gastric surgery: partial gastrectomy, gastroplasty, and vagectomy (but simple ulcer perforation repair or ulcer suture to stop bleeding can be included). 2. Patients who had taken antibiotics, probiotics or prebiotics 4 weeks before treatment, H2RA, PPI or bismuth 2 weeks before treatment and glucocorticoids, immunosuppressants or non-steroidal anti-inflammatory drugs 3 months before treatment. 3. Pregnant or lactating women, or women of reproductive age who do not take reliable contraception. 4. Patients who cannot avoid drinking during the trial. 5. Those who have severe primary diseases of the liver, kidney, heart, brain, lung, endocrine system and hematopoietic system but fail to control effectively. 6. There are contraindications to the test drugs. 7. Patients who require anticoagulant therapy or long-term use of non-steroidal anti-inflammatory drugs (NSAIDs). 8. Subjects with difficulty swallowing. 9. Patients with Zollinger-Ellison syndrome. 10. Patients with malignant tumors. 11. Those who participated in other clinical trials within the first three months of enrollment. 12. Patients who are not suitable for clinical trials as judged by the investigator.

Design outcomes

Primary

MeasureTime frame
the effect of BIFICO combined with quadruple therapy on gastrointestinal microecology;

Secondary

MeasureTime frame
symptom remission rate;H. pylori eradication rate;the rate of side effects;the differences in baseline gastric flora between patients with successful and failed eradication;

Countries

China

Contacts

Public ContactNonghua Lv

The First Affiliated Hospital of Nanchang University

lunonghua@163.com+86 13707086809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026