UMIN-CTR Clinical Trial

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
Email	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
Email	s-sakurai@imeq.co.jp

Sponsor
Institute	Kyodo Milk Industry Co. Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023038