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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039236
Receipt No. R000044690
Scientific Title Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study
Date of disclosure of the study information 2020/01/23
Last modified on 2020/01/23

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Basic information
Public title Efficacy evaluation of a fermented milk drink
Acronym Efficacy evaluation of a fermented milk drink
Scientific Title Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study
Scientific Title:Acronym Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study
Region
Japan

Condition
Condition Subjects with a tendency for constipation
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy evaluation of a fermented milk drink on bowel movements, abdominal feelings, gut environments and gut microbiota of healthy adult with tendency for constipation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bowel movements
Key secondary outcomes Fecal characteristics
Abdominal feelings
Gut environments
Gut microbiota

Base
Study type Interventional

Study design
Basic design Parallel
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 Fermented milk drink
1 bottle/day for 4 weeks
Interventions/Control_2 Placebo drink
1 bottle/day for 4 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects with bowel movements between 3 to 5 times a weeks
2. Subjects having an ability to understand study purpose and detail with voluntary written informed consent
Key exclusion criteria 1. Subjects regularly taking laxatives or drugs effective on digestive systems
2. Subjects taking antibiotics or any drugs affect on microbiota
3. Subjects with severe diseases or metabolic diseases regardless under treatment or not
4. Subjects with chronic diseases and taking drug regularly
5. Subject with history of digestive diseases or digestive surgery
6. Subjects regularly taking any functional food products thought to be effective on constipation
7. Subjects unable to stop taking restricted food such as probiotics, prebiotics and any foods thought to be effective on constipation during test period
8. Subjects with drug or alcohol addiction, and history of these
9. Subjects regularly drinking a lot of alcohol
10. Subject unable to stop taking alcohol on the day before the screening test or sampling feces/ urine
11. Subjects with any food allergies
12. Subjects judged as unsuitable for the study participant on the screening test
13. Subjects participating or willing to participate in any other studies of food, drug and cosmetic
14. Pregnant or lactating women, and those who have possibility to become pregnant during the study period
15. Subjects judged as unsuitable for the study participant by principal investigator from other reasons
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical examination and treatment management family chief director
Zip code 108-0075
Address 5F Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
TEL 03-3452-3382
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 7F Omodaka Bldg., 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Yakult Honsha 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 of Shinagawa Season Terrace Health Care Clinic
Address 5F Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
Tel 03-3452-3382
Email tomohiro_kogo@sempos.or.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
2020 Year 01 Month 23 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 11 Month 21 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 26 Day
Last follow-up date
2020 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 23 Day
Last modified on
2020 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044690

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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