UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008834 |
|---|---|
| Receipt number | R000010376 |
| Scientific Title | Clinical study of combination of Helicobacter pylori eradication therapy and ingestion of bifidobacteria-fermented milk |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2013/04/01 21:40:09 |
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Basic information
Public title
Clinical study of combination of Helicobacter pylori eradication therapy and ingestion of bifidobacteria-fermented milk
Acronym
Clinical study of combination of Helicobacter pylori eradication therapy and ingestion of bifidobacteria-fermented milk
Scientific Title
Clinical study of combination of Helicobacter pylori eradication therapy and ingestion of bifidobacteria-fermented milk
Scientific Title:Acronym
Clinical study of combination of Helicobacter pylori eradication therapy and ingestion of bifidobacteria-fermented milk
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of bifidobacteria-fermented milk on Helicobacter pylori eradication therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urea breath test
H. pylori stool antigen
H. pylori IgG antibody
Pepsinogen I
Pepsinogen II
Pepsinogen I/II
Gastrin
intestinal flora
Intestinal organic acids/metabolite
GSRS
FSSG
ROME III FGID
POMS short version
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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 | Food | Behavior,custom |
Interventions/Control_1
Lactobacillus-fermented milk
Interventions/Control_2
Placebo
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Subjects from 20 to 79 years old
(2)H. pylori-positive subjects
(3)H. pylori positive subjects who wants to be treated with H. pylori eradication therapy
(4)Subjects who can be distinguished between CAM-susceptible and CAM-resistant H. pylori carrier
Key exclusion criteria
(1)Subjects who are allergic to lactobacillus-fermented milk
(2)Subjects with drug allergy
(3)Subjects treated with proton pump inhibitor therapy one month before the screening test
(4)Subjects treated with H. pylori eradication therapy
(5)Subjects with bronchial asthma
(6)Subjects with severe liver disease, renal dysfunction, and heart disease
(7)Subjects judged as unsuitable for this study based on the results of clinical examination
(8)Subjects who participate in other clinical trials
(9)Subjects who are pregnant or lactating, or intending to become pregnant during the study
(10)Subjects judged as unsuitable by the doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Saito |
Organization
Medical Station Clinic
Division name
None
Zip code
Address
3-15-2, Shibaura, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Medical Station Clinic
Division name
None
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Medical Station Clinic
Aisei Hospital, Ueno Clinic
Institute
Department
Personal name
Funding Source
Organization
TTC 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
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
| 2012 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 17 | 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
| 2012 | Year | 09 | Month | 01 | Day |
Last modified on
| 2013 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010376
