UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048232 |
|---|---|
| Receipt number | R000054966 |
| Scientific Title | The eff ect of ingestion of fermented soymilk foods containing lactic acid bacteria and bifi dobacteria in healthy adults double-blind randomized control crossover study. |
| Date of disclosure of the study information | 2022/07/04 |
| Last modified on | 2024/06/03 09:55:53 |
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Basic information
Public title
The eff ect of ingestion of fermented soymilk foods containing lactic acid bacteria and bifi dobacteria in healthy adults double-blind randomized control crossover study.
Acronym
The eff ect of ingestion of fermented soymilk foods containing lactic acid bacteria and bifi dobacteria in healthy adults double-blind randomized control crossover study.
Scientific Title
The eff ect of ingestion of fermented soymilk foods containing lactic acid bacteria and bifi dobacteria in healthy adults double-blind randomized control crossover study.
Scientific Title:Acronym
The eff ect of ingestion of fermented soymilk foods containing lactic acid bacteria and bifi dobacteria in healthy adults double-blind randomized control crossover study.
Region
| Japan |
Condition
Condition
NO
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine eff ects of a test food for the intestinalfunction and its Safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intestinal function:
questionnaire for stool scale(weekly)
stool frequency and number of defecation days(weekly)
Key secondary outcomes
safety:
Hematologic, Blood biochemical test(week0,week4)
Side eff ects/ Adverse events. (week0, week4)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (1 pack a day,4weeks).
Interventions/Control_2
Oral intake of the placebo product (1 pack a day; 4weeks).
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) from 20years old to 65years old.
(2) Individuals whose written informed consent has been obtained after explanation of this study.
Key exclusion criteria
(1) patient
(2) individuals who are sensitive to test product or other foods, and medical products.
(3) individuals judged inappropriate for the study by the principal.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Iwahori |
| Middle name | |
| Last name | Yoshihiro |
Organization
Nihon-pharmaceutical Univercity
Division name
NO
Zip code
362-0806
Address
10281, Komuro, ina-cho, kita-adati-gun, saitama pref. Japan
TEL
08073457947
y-iwahori@nichiyaku.ac.jp
Public contact
Name of contact person
| 1st name | Iwahori |
| Middle name | |
| Last name | Yoshihiro |
Organization
Evidence Marketing LLC
Division name
NO
Zip code
1770031
Address
1-14-26, miharadai, nerima-ku, Tokyo, Japan
TEL
08073457947
Homepage URL
info@evi-ma.com
Sponsor or person
Institute
Evidence Marketing LLC
Institute
Department
Personal name
Funding Source
Organization
KOEI SCIENCE LABORATORY 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
LLC Okutoeru
Address
4-18-21, Minami-aoyama, Minato-ku, Tokyo, Japan
Tel
03-6864-7123
info@okutoeru.com
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 | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jim/36/4/36_199/_pdf
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jim/36/4/36_199/_pdf
Number of participants that the trial has enrolled
20
Results
Subjects who took the test diet containing FF16 (150 mg/day) showed statistically significant improvements in the overall score of the Japanese Constipation Rating Scale, frequency of defecation, anal pain during defecation, and defecation status compared to before the intervention.
Results date posted
| 2024 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were 41-61 years old with 3-5 bowel movements per week.
Participant flow
as above
Adverse events
none
Outcome measures
intestinal function
questionnaire for stool scale(weekly)
stool frequency and number of defecation days(weekly)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Different tests for two test foods (Solution A and Solution B) with the same scientific test name.
Management information
Registered date
| 2022 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054966
