UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects on bowel movements of supplements containing dietary fiber and lactobacillus : a randomized, double blind, placebo-controlled study
Title of the study (Brief title)	Effects on bowel movements of supplements containing dietary fiber and lactobacillus
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate effects of ingestion of supplements containing dietary fiber and lactobacillus for 12 consecutive weeks on bowel movement for normal or tend to be constipated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bowel movements, intestinal flora, comparison of intergroup and intragroup
Key secondary outcomes	examination of the blood

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	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing dietary fiber and lactobacillus for 12 consecutive weeks
Interventions/Control_2	Ingestion of placebo for 12 consecutive weeks
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	1. Males and females between 20 and 60 years of age inclusive 2. Normal or tend to be constipated
Key exclusion criteria	1. Subjects with constipation 2. Subjects with food allergies 3. Subjects who are pregnant or lactating 4. Subjects who consume medicinal product which may influence the outcome of the study 5.Subjects who consume food which may influence the outcome of the study 6. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	50

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan clinical trial association
Division name	N.A.
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	03-6457-4666
Email	info@yakujihou.org

Public contact
Name of contact person	Takeshi Kaneko
Organization	Japan clinical trial association
Division name	N.A.
Address	5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL	03-6457-4666
Homepage URL
Email	jacta@usjri.com

Sponsor
Institute	Japan clinical trial association
Institute
Department

Funding Source
Organization	M. Foods Corporation
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	2017 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 25 Day
Anticipated trial start date	2017 Year 05 Month 30 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 29 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031557