UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-finding study of drink-C containing lactic acid bacteria : A randomized, double blinded, placebo controlled study
Title of the study (Brief title)	Dose-finding study of drink-C containing lactic acid bacteria
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to verify the effect of drink-C containing lactic acid bacteria on defecation and intestinal environment for subjects with constipation tendency
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency, Defecation days. Evaluate two weeks after starting ingestion.
Key secondary outcomes	Stool output, Fecal properties, Intestinal flora (Real-Time PCR)

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of high-dose test product for 2 consecutive weeks
Interventions/Control_2	Ingestion of medium-dose test product for 2 consecutive weeks
Interventions/Control_3	Ingestion of placebo for 2 consecutive weeks
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females from 20 to 64 years of age (2)Subjects who answered that the usual defecation frequency was 2 to 5 times per week in the questionnaire (3)Subjects with a tendency for constipation at 2 to 5 times of defecation per week during screening period
Key exclusion criteria	(1)Subjects who cannot restrict the use of medicines or health foods that may influence their bowel movements after informed consent (2)Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (3)Subjects currently undergoing treatment with digestive diseases that affect the study or have a surgical history of digestive system (except appendicectomy) (4)Subjects with diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or have a history of these diseases (5) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (6)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (7)Subjects need to be on medication or have a history of medication for serious diseases (8)Subjects have possibilities to develop an allergy to the test product (9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (11)Subjects who have participated in other clinical studies (12)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (13)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Jiro Saito
Organization	Medical Station Clinic
Division name	None
Address	3-12-8 Takabann, Meguro-ku, Tokyo, Japan
TEL	03-6452-2712
Email	info@med-station.jp

Public contact
Name of contact person	Chiharu Goto
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo, Japan
TEL	03-5459-5329
Homepage URL
Email	c.goto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Nissin York 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	2017 Year 09 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 24 Day
Anticipated trial start date	2017 Year 09 Month 04 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 09 Month 01 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033134