UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Title of the study (Brief title)	Effects of fermented milk containing Bifidobacterium in healthy adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of intake of fermented milk containing Bifidobacterium for 4 weeks in healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gastrointestinal symptoms at 4 weeks after ingestion of test sample
Key secondary outcomes	Psychological symptoms, Breath test, Salivary stress marker, QOL at 4 weeks after ingestion of test sample

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Fermented milk containing Bifidobacterium intake
Interventions/Control_2	Fermented milk not containing Bifidobacterium intake
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy men and women aged from 20 to 64 years old. 2) 8 and over for modified FSSG score. 3) Subjects who understand details of the study and provides informed consent by documents.
Key exclusion criteria	1) Helicobacter pylori infection 2) Subjects who regularly use gastrointestinal drugs. 3) Functional Dyspepsia 4) Subjects who can't stop the ingestion of probiotics, prebiotics, foods containing lactic acid bacteria, bifidobacteria and other healthy foods which may affect gastrointestinal symptoms. 5) Subjects who have food allergy. 6) Subjects who have severe complication or serious diseases requiring an urgent treatment. 7) Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation. 8) Subjects who are judged as unsuitable for the study by the blood test results of screening test. 9) Subjects who are planning to become pregnant during the study or are pregnant or lactating. 10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 11) Subjects who are planning to participate or already participating in other clinical studies. 12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Yakult Honsha Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 10 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 07 Day
Anticipated trial start date	2016 Year 11 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 31 Day
Last modified on	2018 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028363