UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Bifidobacteria on defecation in healthy volunteers : a randomized, double-blind, placebo-controlled trial.
Acronym	Effect of Bifidobacteria on defecation in healthy volunteers
Scientific Title	Effect of Bifidobacteria on defecation in healthy volunteers : a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym	Effect of Bifidobacteria on defecation in healthy volunteers
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of intervention with Bifidobacteria to defecation in healthy subjects with constipation tendency.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency
Key secondary outcomes	1. Defecation days 2. Fecal amount 3. Stool consistency (Bristol stool scale) 4. Straining during defecation 5. Pain during defecation 6. Feeling of incomplete evacuation after defecation 7. Abdominal bloating 8. Fecal water content 9. QOL 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	Take test food A once a day, 1 capsule, for 2 weeks.
Interventions/Control_2	Take test food B once a day, 1 capsule, for 2 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Males and females from 20 to 64 years of age. 2.Subjects who usually have two or more meals a day. 3.Subjects with constipation tendency at three to five times of defecation per weeks. 4.Subjects with a tendency for hard stool. 5.Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1.Subjects who fall in more than over a quarter to Bristol stool scale 1 or 2. 2.Subjects who are taking medicine. 3.Subjects who are taking health foods which are said to improve constipation at the point of screening examination. 4.Subjects who are having been taken antibacterial drug within 2 weeks at the point of before screening examination. 5.Subjects who are not able to stop ingesting foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods that are said to be good for improving constipation, foods containing a large amount of sugar alcohol, and/or taking antibacterial drugs, laxatives, intestinal regulators, constipation drugs during the study period. 6.Subjects who are consuming large amounts of alcohol on a daily basis. 7.Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation. 8.Subjects with chronic illness who regularly use medicine (including IBS and IBD) 9.Subjects who have food and medicine allergy. 10.Subjects who are affected from or under treatment of serious disease. 11.Subjects who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire. 12.Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 13.Subjects who participate in other clinical trials ,who have participated in other tests within one month of obtaining consent, or who are willing to participate. 14.Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Sagami
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Doctor
Zip code	108-0075
Address	1-2-70 Konan Minato ku Tokyo The 5th floor of Shinagawa season terrace
TEL	03-3452-3382
Email	shibaura@sempos.or.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Biofermin Pharmaceutical 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	5-656-17 Joto-machi, Maebashi-shi, Gumma
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	2022 Year 09 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	120
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	2021 Year 07 Month 27 Day
Date of IRB	2021 Year 08 Month 05 Day
Anticipated trial start date	2021 Year 09 Month 11 Day
Last follow-up date	2021 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 02 Day
Last modified on	2022 Year 09 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051713