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Study on the eradication of Helicobacter pylori infection and its influence on gastrointestinal microbiota by combination therapy of Voronin and Amoxicillin and Bacillus subtilis

A multicenter randomized controlled study on the eradication of Helicobacter pylori infection and its effect on gastrointestinal microbiota by combination therapy of voronin and amoxicillin and Bacillus subtilis.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064869
Enrollment
Unknown
Registered
2022-10-20
Start date
2022-10-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Helicobacter pylori infection

Interventions

Sponsors

Army Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-70 years, no gender limit; 2. Patients diagnosed with chronic gastritis (including atrophic gastritis and non-atrophic gastritis) by gastroscopy in outpatient department were positive by at least two tests: 13C -Urea breath test (13C-UBT), Rapid urease test (RUT) or H.pylori found by histological examination of gastric mucosa; 3. Never received HP eradication treatment before.

Exclusion criteria

Exclusion criteria: 1. Used PPI, P-CAB, H2 receptor antagonists, antibiotics, bismuth, probiotics and other drugs within three months before treatment; 2. Patients who are allergic to the drugs used in this study; 3. There are serious concomitant diseases or malignant tumors; 4. History of colonoscopy, use of laxatives or acute gastroenteritis within 4 weeks prior to treatment; 5. Unhealed gastric ulcer or duodenal bulbous ulcer; 6. Pregnant or lactating patients; 7. Patients with previous gastric and esophageal surgery; 8. Those who cannot sign informed consent.

Design outcomes

Primary

MeasureTime frame
H.pylori infection eradication rate;Intestinal microbiome sample;Gastric microbiome sample;

Secondary

MeasureTime frame
Treat digestive tract symptoms before and after treatment;Adverse event;

Countries

China

Contacts

Public ContactLan Chunhui

Army Medical Center of PLA

lanchunhui@tmmu.edu.cn+86 13896067955

Outcome results

None listed

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