UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study
Title of the study (Brief title)	Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of intake of spore forming lactic acid bacteria containing food 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 at points of 2-week of consumption.
Key secondary outcomes	Intestinal flora (T-RFLP, Real-Time PCR), Stool output, Fecal condition, Questionnaire

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 the test product for 2 consecutive weeks
Interventions/Control_2	Ingestion of placebo for 2 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and Females from 20 to 64 years of age (2)Subjects with a tendency for constipation (three to five times of defecation per week)
Key exclusion criteria	(1)Subjects routinely taking medicine or health food which may influence bowel movement and take foods of lactic acid bacteria. (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 having a surgical history of digestive system (except appendicectomy) (4) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (5) Subjects who are under medication or having a history of serious diseases for which medication was required (6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (8) Subjects having possibilities for emerging allergy related to the study (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (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	Yuko Watanabe
Organization	MITSUBISHI-CHEMICAL FOODS CORPORATION
Division name	Technology Department Division 2
Address	1-1-1,Marunouchi,Chiyoda-ku,Tokyo, Japan
TEL	03-6748-7426
Email	watanabe.yuuko.mw@m-chemical.co.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	MITSUBISHI-CHEMICAL 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	2018 Year 10 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 26 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	Published
URL releasing results
Results	The changes in stool frequency between the two periods in the per protocol population (n=58) were mean3.0 SD3.0 and mean1.6 SD2.9 times/2 weeks in B.coagulans-containing food group and placebo group, respectively (P=0.09). The intergroup difference was significant in the population (n=53) after excluding subjects who took an antibiotic or experienced a change in eating habit (mean3.0 SD3.0 and mean1.2 SD2.8 times/2 weeks in B.coagulans-containing food group and placebo group, respectively, P=0.03). No significant intergroup differences were found in the changes in stool properties, defecation amount, and intestinal flora pattern.
Other related information

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2018 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032998