Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infection

JRCT ID: jRCTs051180155

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 25/03/2019
• Target sample size: 76
• Study type: Interventional

Intervention(s)

Interbention 1: Individuals who receive primary eradication treatment for H. pylori infection are taken Bioferumin R powder 3 g/day for two weeks from the first day of eradication treatmen.
Interbention 2: Individuals who receive primary eradication treatment for H. pylori infection are taken 3 g/day of potato starch powder for two weeks from the first day of eradication treatmen.

Outcome(s)

• Primary Outcome: The occurrence of diarrea during H. pylori eradication therapy (day 0 to day 6) in biofermin R administration group and placebo group.

Secondary Outcome

1.Gut microflora change (alpha and beta divesity change) at day7, day 14 and pont of judgement after eradication therapy
2.Occurrence of side effect other than diarrhea
3.FSSG scal score before and after therapy
4.Serum diamine oxydase activity before and after therapy
5.Occurence of diarrhea after eradication therapy (between day 7 to day 13)
6.Number of defecations during and 7 days after antibiotic treatment.
7.Percentage of stool properties in the Bristol Stool Form Scores during and 7 days after antibiotic treatment.
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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Inoue Jun
• Source(s) of Monetary Support: Biofermin Seiyaku Co., Ltd.
• Secondary ID(s): UMIN000030015