UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Synergy effect when probiotics and prebiotics eaten together
Title of the study (Brief title)	Synergy effect when probiotics and prebiotics eaten together
Region	Japan

Condition
Condition	Constipation and intestinal dysbiosis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the synergy effect when probiotics and prebiotics eaten together on stool frequency and intestinal microbiota in Japanese young women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	change in stool frequency and intestinal microbiota after supplementation of test foods for 2 weeks
Key secondary outcomes	questionnaire survey about eating behavior and psychosomatic state

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	intake of test food containing Bifidobacterium lactis HN019 1 billion, CFU/3.33mg, daily with 100ml water or milk for 2 weeks
Interventions/Control_2	intake of test food containing6.25g polydextrose daily with 100ml water or milk for 2 weeks
Interventions/Control_3	intake of test food containing Bifidobacterium lactis HN019 1 billion, CFU/3.33mg, daily and 6.25g polydextrose daily with 100ml water or milk for 2 weeks
Interventions/Control_4	intake of placebo food containing 6.25g dextrin daily with 100ml water or milk for 2 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) age more than 18 years old at consent and must be an Otsuma Women's University student 2) subjects understand the study procedures and agree to participate in the study by giving informed consent prior to the study
Key exclusion criteria	1) has history of cardiovascular diseases, liver disease, kidney disease digestive tract disease, respiratory disease, diabetes 2) has history of malignant disease or now on chronic disease therapy 3) takes drugs to treat disease 4) has history of drug and food allergy 5) has continuous intake of dietary fiber supplement (dietary fiber rich foods made with seaweed, konjak, psyllium etc) or whole grain cereals(whole grain wheat, brown rice, barley) 6) Females who are pregnant or lactating, and who could become pregnant during test period. 7) has smoking habit 8) Subjects who are participating the other clinical tests. Subjects who participated within 1-month prior to the current study and/or who plan to participate the other clinical tests. 9) has history of drug addiction or in therapy for drug addiction 10) Subject whose stool frequency is more than 5 days weekly 11) is not appropriate in the investigator's opinion
Target sample size	28

Research contact person
Name of lead principal investigator	Seiichiro Aoe
Organization	Otsuma Women's University
Division name	Fuculty of Home Economics
Address	12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL	03-5275-6048
Email	s-aoe@otsuma.c.jp

Public contact
Name of contact person	Hideki Sakanishi
Organization	Danisco Japan Inc.
Division name	Nutrition and Health
Address	Sanno Park Tower 11-1, Nagata-Cho 2-chome, Chiyoda-ku, 100-6111,Tokyo
TEL	03-5521-2427
Homepage URL
Email	Hideki.Sakanishi@dupont.com

Sponsor
Institute	Otsuma Wonmen'w University Fuculty of Home Economics
Institute
Department

Funding Source
Organization	Danisco Japan Inc. Nutrition and Health
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	大妻女子大学家政学部

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 12 Month 04 Day
Last follow-up date	2017 Year 04 Month 10 Day
Date of closure to data entry	2017 Year 04 Month 14 Day
Date trial data considered complete	2017 Year 04 Month 25 Day
Date analysis concluded	2017 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.oatext.com/pdf/IMM-4-306.pdf
Results	The intake of polydextrose for 2 weeks increased the proportion of fecal Bacteroides. The combined intake of probiotics and prebiotics may increase stool amounts via increasing the proportion of Bacteroides among the fecal microbiota.
Other related information

Management information
Registered date	2017 Year 04 Month 06 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030843