UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036843 |
|---|---|
| Receipt number | R000041974 |
| Scientific Title | Effects of Lactic Acid Bacteria and Bifidobacterium-containing Supplements on Intestinal Flora : a randomized, double-blind, placebo-controlled, cross-over trial. |
| Date of disclosure of the study information | 2019/05/28 |
| Last modified on | 2020/04/14 09:38:53 |
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Basic information
Public title
Effects of Lactic Acid Bacteria and Bifidobacterium-containing Supplements on Intestinal Flora
Acronym
Enteric flora trial
Scientific Title
Effects of Lactic Acid Bacteria and Bifidobacterium-containing Supplements on Intestinal Flora : a randomized, double-blind, placebo-controlled, cross-over trial.
Scientific Title:Acronym
Enteric flora trial
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of test product intake on intestinal flora
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency and days of defecation and intestinal environment.
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test article twice daily for 2 weeks
Interventions/Control_2
Ingestion of placebo article twice daily for 2 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Males and females between 20 and 59 years of age inclusive
2. Normal or tend to be constipated
Key exclusion criteria
1. Subjects with constipation
2. Subjects with food allergies
3. Subjects who are pregnant or lactating
4. Subjects who consume medicinal product which may influence the outcome of the study
5.Subjects who consume food which may influence the outcome of the study
6. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Masatomo |
| Middle name | |
| Last name | Najima |
Organization
Japan clinical trial assosiation
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan clinical trial assosiation
Institute
Department
Personal name
Funding Source
Organization
Kenkoutsuhan 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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2019 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
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
| 2019 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041974
