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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036843
Receipt No. 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 2019/05/24

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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
Email 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
Email info@yakujihou.org

Sponsor
Institute Japan clinical trial assosiation
Institute
Department

Funding Source
Organization Tetsuro Hirashima
Organization
Division
Category of Funding Organization Self funding
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
Email 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 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 18 Day
Date of IRB
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
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041974

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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