UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047859 |
|---|---|
| Receipt number | R000053965 |
| Scientific Title | Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial- |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2023/05/26 09:35:41 |
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Basic information
Public title
Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial-
Acronym
Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial-
Scientific Title
Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial-
Scientific Title:Acronym
Effect of silk extract fermented with lactic acid bacteria on bowel movement -a randomized, double-blind, placebo-controlled clinical trial-
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of silk extract fermented with plant-derived lactic acid bacteria on bowel movement and fecal microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in defecation frequency after 12-week intake period
Key secondary outcomes
Changes in following items after 12-week intake period:
Bristol stool form score,
fecal microbiota,
skin moisture,
blood total IgE,
body mass index,
body fat percentage,
blood glucose,
serum AST, ALT and gamma-GTP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of fermented (by lactococcus lactis BM32-1) silk extract drink (100 mL/day) for 12 weeks.
Interventions/Control_2
Intake of placebo drink (without silk extract and lactic acid bacteria) (100 mL/day) for 12 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy male and female with defecation frequency <=4 times/week
Key exclusion criteria
1) Allergy to silk, apple, and milk
2) Taking large volume of silk proteins habitually
3) Taking medicines for chronic disease
4) Predicted to be sick after screening
5) In pregnancy or nursing a child
6) Taking drugs that may affect the defecation frequency and intestinal microbiota
7) Participation in any clinical trial within 90 days of the commencement of the trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School of Biomedical and Health Sciences
Hiroshima University
Division name
Probiotic Science for Preventive Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5288
bel@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Graduate School of Biomedical and Health Sciences Hiroshima University
Division name
Probiotic Science for Preventive Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5288
Homepage URL
bel@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Kimono brain 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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.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
| 2022 | Year | 05 | Month | 25 | 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
| 2022 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 03 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053965
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
