Safety Clinical Trial
Official title:
The Effects of Compound Lactobacillus Acidophilus Has on Gastromicroecology and Combined With Tetracycline- and Furazolidone- Containing Quadruple Regimen as Rescue Treatment for Helicobacter Pylori Infection
This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 15, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures. Exclusion Criteria: - Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding. |
Country | Name | City | State |
---|---|---|---|
China | Changhai hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Yiqi Du |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | gene-level changes in the gastric microbiota | study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics | 2 weeks | |
Secondary | eradication rate of the therapy | using the 13C-urea breath test at 4 weeks after the end of therapy | 4 weeks | |
Secondary | the incidence of the adverse effects | record the side effects on the 2 week, 4 week. | 2 weeks, 4 weeks |
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