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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018976
Receipt No. R000021953
Scientific Title A study for evaluating the effect of the intake of a Lactobacillus containing food on retaining moisture of the skin in adult female with a tendency for constipation:double blind, placebo-controlled study
Date of disclosure of the study information 2016/09/11
Last modified on 2016/03/10

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Basic information
Public title A study for evaluating the effect of the intake of a Lactobacillus containing food on retaining moisture of the skin in adult female with a tendency for constipation:double blind, placebo-controlled study
Acronym A study for evaluating the effect of the intake of a Lactobacillus containing food on retaining moisture of the skin in adult female with a tendency for constipation
Scientific Title A study for evaluating the effect of the intake of a Lactobacillus containing food on retaining moisture of the skin in adult female with a tendency for constipation:double blind, placebo-controlled study
Scientific Title:Acronym A study for evaluating the effect of the intake of a Lactobacillus containing food on retaining moisture of the skin in adult female with a tendency for constipation
Region
Japan

Condition
Condition tendency toward constipation
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the improvement effects of ingestion of a Lactobacillus containing food on retaining moisture of the skin and bowel movement in adult female with a tendency for constipation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes moisture content of the stratum corneum, transepidermal water loss
Key secondary outcomes defecation frequency, defecation days, stool output, fecal condition, skin questionnaire

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 Prevention
Type of intervention
Food
Interventions/Control_1 intake of a test food containing with lactobacillus for 8 consecutive weeks
Interventions/Control_2 intake of a placebo for 8 consecutive 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
64 years-old >=
Gender Female
Key inclusion criteria (1) Females from 20 to 64 years of age
(2) Subjects with a tendency for constipation at three to five times of defecation per week
Key exclusion criteria (1) Subjects who routinely takes foods or medicines containing of lactobacillus
(2) Subjects who routinely takes foods or medicines which may influence bowel movement or skin
(3) Subjects having diseases affecting bowel movement or a history of these diseases
(4) Subjects who hase treated cosmetic care
(5) Subjects who has treated cosmetic care except for measuring sites, or hormonal therapy for one year
(6) Subjects who got a facial, a wash-rag, lost hair on measuring sites for one month ago, or plans these actions.
(7) Subjects who washes the body using a nylon towel which provides strong skin irritation
(8) Subjects who has the wound or inflammatory disease affecting the measuring skin
(9) Subjects who has asthma or the possibility of asthma
(10) Subjects who has being excepted to be developed the allergy symptoms on skin
(11) Subjects who feels to trouble by rough skin around a menstruates
(12) Subjects who is employed on a pre-dawn shift or on night duty more than 2 times
(13) Subjects who is planned to go overseas
(14) Subjects who has treatment or a history of serious disease or affecting a secretion of sex hormones
(15) Subjects having possibilities for emerging allergy related to the study
(16) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening test
(17) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(18) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(19) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(20) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehisa Kumagai
Organization KAMEDA SEIKA CO., LTD.
Division name RICE RESEARCH INSTITUTE
Zip code
Address 3-1-1 Kameda Kogyo Danchi, Konan-ku, Niigata City, Niigata
TEL 025-382-8879
Email t_kumagai@sk.kameda.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Tsuji
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

Funding Source
Organization KAMEDA SEIKA 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
Address
Tel
Email

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
2016 Year 09 Month 11 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
2015 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 10 Day
Last modified on
2016 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021953

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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