UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized, placebo controlled, crossover study
Acronym	Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition
Scientific Title	Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized, placebo controlled, crossover study
Scientific Title:Acronym	Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the efficacy of the dietary fiber-containing food on gastrointestinal condition
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number and ratio of fecal Bifidobacterium Defecation frequency
Key secondary outcomes	Defecation days, stool volume, stool shape, stool color, stool smell and the feeling after defecation Intestinal microflora analysis Fecal ammonia measurement Fecal pH measurement Fecal water content measurement Stool weight

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Taking a control food for 14 days -> Washout period for 21 days -> Taking a test food at low dose for 14 days -> Washout period for 21 days -> Taking a test food at high dose for 14 days
Interventions/Control_2	Taking a test food at low dose for 14 days -> Washout period for 21 days -> Taking a test food at high dose for 14 days -> Washout period for 21 days -> Taking a control food for 14 days
Interventions/Control_3	Taking a test food at high dose for 14 days -> Washout period for 21 days -> Taking a control food for 14 days -> Washout period for 21 days -> Taking a test food at low dose for 14 days
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)Healthy males and females from 20 to 64 years old 2)Subjects with defecation at three to five times per week 3)Subjects with fewer number and lower ratio of Bifidobacterium in feces 4)Subjects who have received written informed consent
Key exclusion criteria	1) Subjects who regularly use laxatives 2) Subjects who regularly take foods which may affect gastrointestinal condition 3) Subjects who regularly use antibiotics and other medicines which affect digestion and absorption 4) Subjects who cannot abstain from taking foods which are containing viable bacteria, enriched with oligosaccharides or dietary fiber, considered effective for constipation improvement and are containing large amount of sugar alcohol 5) Subjects who have allergy for foods 6) Subjects who regularly take too much alcohol 7) Subjects who have diseases which require urgent treatment or severe complications 8) Subjects who have gastrointestinal diseases or a surgical history which may affect digestion, absorption and defecation 9) Subjects who are pregnant, lactating or planning to be pregnant in the test period 10) Subjects who are under treatment or have a history of drug addiction or alcoholism 11) Subjects who are participating or planning to participate in a clinical study 12) Subjects who are judged as inappropriate by investigator
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Satoru Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical examination and treatment management family chief director
Zip code
Address	1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL	03-3452-3381
Email	satoru_suzuki@sempos.or.jp

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

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	KOBAYASHI 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
Address
Tel
Email

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 03 Month 13 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	2018 Year 02 Month 09 Day
Date of IRB	2018 Year 02 Month 23 Day
Anticipated trial start date	2018 Year 03 Month 13 Day
Last follow-up date	2018 Year 08 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036196