UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single center, double-blind, randomized, parallel trial to evaluate the efficacy of food containing yeast on human gastrointestinal function
Title of the study (Brief title)	Evaluation study of the efficacy on human gastrointestinal function
Region	Japan

Condition
Condition	Slight constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy of food containing yeast in improving constipation after 12-week intake
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Defecation frequency, defecation days(After intervention 11-12 weeks after)
Key secondary outcomes	Amount of defection, fecal condition(form, color, smell, feeling after defecation)

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	food containing yeast 12-week intake(Three times a day intake)
Interventions/Control_2	Placebo 12-week intake(Three times a day 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)Japanese male and female ages 20-64 years old (inclusive) (2)Subjects with tendency for constipation at 3 to 5 times of defecation per week (3)Subjects who take 3 meals per day regularly (4)Willing and able to provide signed written informed consent
Key exclusion criteria	(1)Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders (2)Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment (3)Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system ( except appendectomy) (4)Subjects who suffer from diseases/ disorders that affects bowel movement such as irritable bowel syndrome or ulcerative colitis etc or have medical history of above-mentioned diseases/ disorders (5)Subjects with history of sensitivity to the ingredients (6)Pregnant, lactating women or willing to be pregnancy during the study (7)Subjects who take any kind of medicine ( laxative, intestinal drug etc) that possibly affect bowel movement (8)Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) regularly that possibly affect bowel movement (9)Subjects who have a habit of eating lactic fermenting beverage or food or Lactobacillus preparation that contain many lactobacillus, food fortified with dietary fiber and/or oligosaccharide 3 and more times per week (10)Any candidate considered to be unsuitable for enrollment based on his/her answers of life style questionnaire (11)Subjects who had participated in other clinical trials including drug and food within 1 month. (12)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Shukuko Ebihara
Organization	Chiyoda Paramedical Care Clinic
Division name	Chiyoda Paramedical Care Clinic
Address	3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL	03-5297-5548
Email	m.n@cpcc.co.jp

Public contact
Name of contact person	Shigeru Imai
Organization	CROee Inc.
Division name	Evidence Division
Address	1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
TEL	03-5953-2108
Homepage URL
Email	imai@croee.com

Sponsor
Institute	Prime Biz Corporation
Institute
Department

Funding Source
Organization	Prime Biz Corporation
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	チヨダパラメディカルケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 01 Month 08 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 08 Month 04 Day
Date analysis concluded	2016 Year 10 Month 30 Day

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

Management information
Registered date	2016 Year 01 Month 07 Day
Last modified on	2018 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023654