The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection
- Conditions
- SafetyGastric MicrobiotaEfficacy
- Interventions
- Other: Compound Lactobacillus acidophilus
- Registration Number
- NCT03377933
- Lead Sponsor
- Yiqi Du
- Brief Summary
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.
- Detailed Description
Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, \<10% show H. pylori related dyspepsia, 15%\~20% develop into peptic ulcer, \<1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases.
With the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians.
Besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate.
Investigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description probiotics and quadruple therapy Compound Lactobacillus acidophilus Patients are given two-week compound Lactobacillus acidophilus probiotic (1 g t.i.d.), followed by a quadruple antibiotic regimen (esomeprazole \[20 mg b.i.d.\] + bismuth potassium citrate \[220 mg b.i.d.\] + tetracycline \[750 mg b.i.d.\] + furazolidone \[100 mg b.i.d.\]) for 10 days as rescue therapy.Meanwhile perform endoscopy and take gastric mucosa specimens for gene sequencing before and after the application of probiotic.
- Primary Outcome Measures
Name Time Method gene-level changes in the gastric microbiota 2 weeks study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics
- Secondary Outcome Measures
Name Time Method the incidence of the adverse effects 2 weeks, 4 weeks record the side effects on the 2 week, 4 week.
eradication rate of the therapy 4 weeks using the 13C-urea breath test at 4 weeks after the end of therapy
Trial Locations
- Locations (1)
Changhai hospital
🇨🇳Shanghai, China