UMIN-CTR Clinical Trial

Basic information
Public title	A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial.
Acronym	A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment.
Scientific Title	A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment. A placebo-controlled, randomized, double-blind, cross-over trial.
Scientific Title:Acronym	A study (study No. 2) for evaluating the effects of intake of food containing lactic acid bacteria and oligosaccharide on intestinal environment.
Region	Japan

Condition
Condition	Subjects with a tendency for constipation
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of food B containing lactic acid bacteria and oligosaccharide on intestinal environment of subjects with a tendency for constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of Lactobacillus genus in feces
Key secondary outcomes	Number of Bifidobacterium genus in feces, organic acids(Lactic acid, succinic acid, formic acid, acetic acid, propionic acid, iso-butyric acid, n-butyric acid, iso-valeric acid, n-valeric acid) content in feces, decay product(Indole, p-cresol, skatole, phenols) content in feces, ammonia content in feces, Number of Lactobacillus brevis species in feces, questionnaire(Defecation days, defecation frequency, fecal amount, fecal shape, fecal color, fecal odor, feeling after defecation)

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	Food B containing lactic acid bacteria and oligosaccharide (2 weeks intake) - washout period (2 weeks) - placebo (not containing lactic acid bacteria and oligosaccharide) (2 weeks intake)
Interventions/Control_2	Placebo (not containing lactic acid bacteria and oligosaccharide) (2 weeks intake) - washout period (2 weeks) - food B containing lactic acid bacteria and oligosaccharide (2 weeks 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) Males and females from 20 to 64 years of age (2) Subjects with a tendency for constipation at three to five times of defecation per week at the point of screening examination(2 weeks) (3) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) in common use (2) Individuals taking health foods in common use, which influence intestinal regulation at the point of screening examination (3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination (4) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use and food with function claim, which influence intestinal regulation during the study period (5) Individuals presenting known food allergy (6) Individuals taking large amounts of alcohol on a daily basis (7) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (8) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (9) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire (10) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (11) Individuals who are under treatment or have a history of drug/alcohol dependence (12) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13-4 Nihonbashikodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel	027-212-5608
Email	sagawa@mc-connect.co.jp

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	2019 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 11 Month 21 Day
Date of IRB	2019 Year 11 Month 21 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 07 Day
Date of closure to data entry	2020 Year 05 Month 20 Day
Date trial data considered complete	2020 Year 05 Month 20 Day
Date analysis concluded	2020 Year 06 Month 05 Day

Other
Other related information

Management information
Registered date	2019 Year 11 Month 29 Day
Last modified on	2020 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044144