UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019957 |
|---|---|
| Receipt number | R000023038 |
| Scientific Title | Effect of milk that produce hydrogen gas in the gut on breath hydrogen excretion |
| Date of disclosure of the study information | 2015/11/27 |
| Last modified on | 2020/03/02 15:49:48 |
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Basic information
Public title
Effect of milk that produce hydrogen gas in the gut on breath hydrogen excretion
Acronym
Effect of milk that produce hydrogen gas in the gut on breath hydrogen excretion
Scientific Title
Effect of milk that produce hydrogen gas in the gut on breath hydrogen excretion
Scientific Title:Acronym
Effect of milk that produce hydrogen gas in the gut on breath hydrogen excretion
Region
| Japan |
Condition
Condition
Chronic inflammation
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral administration of test-milk, which produce hydrogen gas in the gut, on breath hydrogen excretion in healthy volunteers
Basic objectives2
Others
Basic objectives -Others
To investigate the transport of hydrogen gas produced in the gut to breath excretion
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of breath hydrogen concentration after oral intake of test-milk
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Volunteers are given an oral administration of 200 ml test-milk containing non-digestible polysaccharides and collected breath every hour for 12 hours. In second and third week, volunteers are given an oral administration of 200 ml normal milk and commercial hydrogen water, respectively. These breath haydrogen concentration are mesured.
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men
Key exclusion criteria
1. Volunteers with milk allergy
2. Volunteers with serious lactose intolerance
3. Volunteers who have serious constipation
4. Volunteers who were enrolled in other trails within three month
5. Inappropriate cases evaluated by doctors
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
190-0182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182
TEL
0425975911
m-matumoto@meito.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Sakurai |
Organization
imeQ CO. Ltd.
Division name
CRO division
Zip code
169-0051
Address
a vous primus Bld, 2-14-6, Nishiwaseda, Shinjuku-ku 169-0075
TEL
03-6205-6222
Homepage URL
s-sakurai@imeq.co.jp
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Keio University School of medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
CIryouhoujinsyadan Hakusuikai Suda linical Institutional Review Board
Address
2-8-14 Takadanobaba, Shinjuku-ku, Tokyo 169-0051, Japan
Tel
03-6205-6222
suda-clinic_irb@imeq.co.jp
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
医療法人社団 慈昴会 白石内科クリニック
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 27 | 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
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
