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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028109
Receipt No. 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 2017/07/06

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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
Email 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
Email m-matumoto@meito.co.jp

Sponsor
Institute Kyodo Milk Industry Co. Ltd.
Institute
Department

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
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 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 15 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 07 Month 06 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032165

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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