UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028109 |
|---|---|
| Receipt number | R000032165 |
| Scientific Title | Effect of long-term intake of milk that produce hydrogen gas in the gut on breath hydrogen excretion and intestinal microbiota |
| Date of disclosure of the study information | 2017/07/15 |
| Last modified on | 2020/03/02 15:55:55 |
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Basic information
Public title
Effect of long-term intake of milk that produce hydrogen gas in the gut on breath hydrogen excretion and intestinal microbiota
Acronym
Effect of long-term intake of milk that produce hydrogen gas in the gut on breath hydrogen excretion and intestinal microbiota
Scientific Title
Effect of long-term intake of milk that produce hydrogen gas in the gut on breath hydrogen excretion and intestinal microbiota
Scientific Title:Acronym
Effect of long-term intake of milk that produce hydrogen gas in the gut on breath hydrogen excretion and intestinal microbiota
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the effect of long-term intake of milk that produce hydrogen gas in the gut on breath hydrogen excretion and intestinal microflora.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Breath hydrogen concentration
Key secondary outcomes
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The volunteer are given test milk (200 ml/day) for 4 months without specific dietary restrictions
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 and Female
Key inclusion criteria
Healthy adults
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. Volunteers who complained of malfunction
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuharu Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182
TEL
042-597-5911
m-matumoto@meito.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuharu Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182
TEL
042-597-5911
Homepage URL
m-matumoto@meito.co.jp
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 07 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 07 | Month | 06 | 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=R000032165
| Research Plan | |
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| 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 |
