UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031693 |
|---|---|
| Receipt number | 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 09:42:00 |
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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
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
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036196
