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The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial (Transitioned to jRCT)

The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial (Transitioned to jRCT) - Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030015
Enrollment
76
Registered
2017-12-18
Start date
2018-02-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Helicobacter pylori infection

Interventions

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. Individuals who receive pr

Sponsors

Kobe University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
The occurrence of diarrea during H. pylori eradication therapy (day 0 to day 6) in biofermin R administration group and placebo group.

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactJun Inoue

Kobe University Hospital Gastroenterology

juninoue@med.kobe-u.ac.jp(+81)783825111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026