UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Title of the study (Brief title)	Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of the test food on the regulation of intestinal function in constipation-prone men and women aged 20 to 65 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intestinal flora , Defecation frequency, Fecal amount , Bristol Stool Form Scale
Key secondary outcomes	Vital signs

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	2-week intake of the test food Wash out 2-week intake of the placebo
Interventions/Control_2	2-week intake of the placebo Wash out 2-week intake of the test food
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)Age: 20 years or older, under 65 years of age 2)Gender: Japanese males and females 3)Persons who have had 3 to 5 bowel movements per week
Key exclusion criteria	1)People who regularly drink or drink yogurt containing lactobacilli*Yogurt consumption will not be excluded if habit exists during the study. 2)Patients who cannot limit the use of drugs that may affect bowel movements (e.g., laxatives, intestinal regulators), health foods, specified health foods, functional labeling foods, health . 3)Subjects who were attending the hospital for bowel movements illness at study entry and were taking medications or taking over-the-counter laxatives. 4)Persons who are currently receiving treatment at a medical institution for gastrointestinal diseases that have an effect on the regulation of intestinal function, or those who have undergone. 5)Persons with or with a history of diseases that may significantly affect bowel movements, such as irritable bowel disease and ulcerative colitis. 6)Persons with or with a history of diseases such as diabetes, liver disease, kidney disease, or heart disease. 7)Persons currently undergoing exercise and diet therapy under the supervision of a physician. 8)Persons with diseases requiring constant medication. 9)Persons with a history of serious disease requiring medical treatment. 10)Persons with a history of drug or food allergy. 11)Subjects who are judged inappropriate as subjects based on the responses to the background questionnaire. 12)Subjects with significant deviations from reference ranges in pre-test physical, physical, and laboratory measurements. 13)Pregnant, lactating women, or women who wish to become pregnant during the study. 14)Persons with a current or past history of psychiatric disorders (e.g., depression). 15)Persons who work shift, such as night shift workers. 16)Patients who are receiving or have a history of drug dependence or drug abuse. 17)Individuals who have participated in other human clinical studies or are currently participating in other human clinical studies within the past 3 months. 18)Other subjects who are considered inappropriate as subjects by the investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Pickles 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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 13 Day
Anticipated trial start date	2018 Year 06 Month 01 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	2018 Year 04 Month 27 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036956