UMIN-CTR Clinical Trial

Basic information
Public title	Effect confirmation test of probiotics food : BFF004, BFF003 for healthy adults with constipation tend - Open method -
Acronym	Effect confirmation test of probiotics food : BFF004,BFF003 for healthy adults with constipation tend
Scientific Title	Effect confirmation test of probiotics food : BFF004, BFF003 for healthy adults with constipation tend - Open method -
Scientific Title:Acronym	Effect confirmation test of probiotics food : BFF004,BFF003 for healthy adults with constipation tend
Region	Japan

Condition
Condition	Healthy adult with a tendency for constipation
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of test food (probiotics) on the 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	Defecation frequency
Key secondary outcomes	16S rRNA metagenome analysis by next generation sequencer of intestinal bacterial flora. Intestinal metabolite (metabolome analysis). Satisfaction (VAS).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest probiotics food:BFF004 three times a day, 1 package after meals for 2 weeks.
Interventions/Control_2	Ingest probiotics food:BFF003 three times a day, 1 package after meals 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 with a tendency for constipation at three to five times of defecation per week at the point of screening examination. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1)Subjects who falls in more than half a week to Bristol scale 1. (2)Subjects who taking medicine. (3)Subjects who taking health foods which is said to improve constipation at the point of screening examination. (4)Subjects who having been taken ntestinal preparation and/or antibacterial drug within 2 weeks at the point of screening examination. (5)Subjects 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, which influence intestinal regulation during the study period. (6)Subjects who 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 who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire. (9)Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (10)Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics. (11)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Head of medical examination department
Zip code	108-0075
Address	Shinagawa Season Terrace 5F, 1-2-17 Minatominami, Minato-ku, Tokyo
TEL	03-3452-3381
Email	satoru_suzuki@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	Yoshi@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	Shinagawa Season Terrace Health Care Clinic
Address	1-2-17 Minatominami, Minato-ku, Tokyo
Tel	03-3452-3381
Email	tomohiro_kogo@sempos.or.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	2024 Year 03 Month 31 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	100
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	2018 Year 06 Month 15 Day
Date of IRB	2018 Year 06 Month 01 Day
Anticipated trial start date	2018 Year 09 Month 15 Day
Last follow-up date	2018 Year 12 Month 04 Day
Date of closure to data entry	2019 Year 04 Month 12 Day
Date trial data considered complete	2019 Year 05 Month 17 Day
Date analysis concluded	2019 Year 06 Month 28 Day

Other
Other related information

Management information
Registered date	2019 Year 12 Month 03 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041391