Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infectio
- Conditions
- Helicobacter pylori infection
- Registration Number
- JPRN-jRCTs051180155
- Lead Sponsor
- Inoue Jun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 76
(1) Patient who was suspected for H. pylori infection and were positive for H. pylori in one of the following examination, urea breath test, H. pylori stool antigen test, H.pylori antibody test in the urine or in the blood, rapid urease test.
(2) Patient who is expected an beneficial effect after H.pylori radication treatment.
(3) Patients written consent from the person is obtained.
(4) Patients without allergy to the use drugs.
(1) Patients who have already taken H. pylori eradication therapy before.
(2) Patients who had taken any antibiotics or PPI within 4 weeks before the start day of the study.
(3) Patients under 20 years.
(4) Patients who had taken gastric cancer sugery before (except endoscopic surgery).
(5) Patients with severe renal impairment, serious heart disease, or severe liver disease.
(6) Patients with allergy to the use drugs.
(7) In the cases the test doctor has determined the patient does not fit the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of diarrea during H. pylori eradication therapy (day 0 to day 6) in biofermin R administration group and placebo group.
- Secondary Outcome Measures
Name Time Method 1.Gut microflora change (alpha and beta divesity change) at day7, day 14 and pont of judgement after eradication therapy <br>2.Occurrence of side effect other than diarrhea <br>3.FSSG scal score before and after therapy <br>4.Serum diamine oxydase activity before and after therapy <br>5.Occurence of diarrhea after eradication therapy (between day 7 to day 13)<br>6.Number of defecations during and 7 days after antibiotic treatment. <br>7.Percentage of stool properties in the Bristol Stool Form Scores during and 7 days after antibiotic treatment.<br>A stratified analysis will be performed on the primary endpoint and secondary endpoints based on background items (age, gender, etc) to examine the influence of patient background.