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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030015
Receipt No. R000034265
Scientific Title The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial
Date of disclosure of the study information 2017/12/18
Last modified on 2018/07/30

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Basic information
Public title The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial
Acronym Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infection
Scientific Title The effect of antibiotic-resistant lactic acid bacteria on adverse events of H. pylori eradication therapy: A randamized control trial
Scientific Title:Acronym Study of antibiotic-resistant lactic acid bacteria cobination eradication therapy for H. pylori infection
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine the effect of Bifermin R, antibiotic-resistant lactic acid bacteria, on adverse events (mainly diarrhea) of H. pylori eradication therapy and its preventive effect against antibiotics-associated gut microbiota dysbiosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence of diarrea during H. pylori eradication therapy (day 0 to day 6) in biofermin R administration group and placebo group.
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_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.
Interventions/Control_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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 76

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Umegaki
Organization Kobe University Hospital
Division name Gastroenterology
Zip code
Address 7-5-2 Kusunoki-cho Chuo-ku Kobe-city Japan
TEL (+81)783825111
Email eumegaki@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Inoue
Organization Kobe University Hospital
Division name Gastroenterology
Zip code
Address 7-5-2 Kusunoki-cho Chuo-ku Kobe-city Japan
TEL (+81)783825111
Homepage URL
Email juninoue@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Biofermin Seiyaku Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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