UMIN-CTR Clinical Trial

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