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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031693
Receipt No. R000036196
Scientific Title Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized, placebo controlled, crossover study
Date of disclosure of the study information 2018/03/13
Last modified on 2019/03/13

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000036196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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