UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038920 |
|---|---|
| Receipt number | R000044377 |
| Scientific Title | A study for skin condition and intestinal effect by intake of Spore-forming lactic acid bacteria for constipations. - A placebo-controlled, randomized, double-blind, cross-over trial- |
| Date of disclosure of the study information | 2019/12/18 |
| Last modified on | 2020/06/17 09:43:23 |
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Basic information
Public title
A study for skin condition and intestinal effect by intake of Spore-forming lactic acid bacteria for constipations. - A placebo-controlled, randomized, double-blind, cross-over trial-
Acronym
A study for skin condition and intestinal effect by intake of Spore-forming lactic acid bacteria for constipations.
Scientific Title
A study for skin condition and intestinal effect by intake of Spore-forming lactic acid bacteria for constipations. - A placebo-controlled, randomized, double-blind, cross-over trial-
Scientific Title:Acronym
A study for skin condition and intestinal effect by intake of Spore-forming lactic acid bacteria for constipations.
Region
| Japan |
Condition
Condition
Adult woman with a tendency for constipation.
Classification by specialty
| Gastroenterology | Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of taking Spore-forming lactic acid bacteria on the skin condition and intestinal environment, and clarify the functionality of Spore-forming lactic acid bacteria. Also examine the synergistic effect of combination with oligosaccharide.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin measurement(at screening test, 0, 4 and 8weeks)
1. Stratum corneum moisture content
2. transepidermal water loss
3. skin viscoelasticity
4. Melanin content
5. Skin texture
6. Skin color
7. Skin image measurement
Key secondary outcomes
1. Defecation frequency, Amount of defecation, Stool shape, Stool color, Smell of stool, Sensation after defecation from subject diary.
2. Stool inspection
3. 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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take 1 capsule of test food(1) with 1 drink of 280 ml, once a day for 8 weeks.
Interventions/Control_2
Take 1 capsule of test food(2) with 1 drink of 280 ml, once a day for 8 weeks.
Interventions/Control_3
Take 1 capsule of control food with 1 drink of 280 ml, once a day for 8 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Females from 30 to 50 years of age who wrote that the number of defecations per week was 3-5 times a week in the subject diary brought at the screening test.
(2) Subjects who are concerned about skin color due to dry skin and sunburn.
(3) Subjects whose stratum corneum moisture at the intersection of the corner of the eye and the nose is less than 60 AU at the screening test.
(4) Subjects who have few Bifidobacterium and lactic acid bacteria, and a small percentage of the total number of bacteria in the stool sampled at the screening test.
(5) Subjects who can ban alcohol from the day before the test date.
(6)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who regularly take medicines and health foods that are said to having an effect on the skin.
(2) Subjects who suffers from urgent medical treatment or has serious complications.
(3) Subjects who has symptoms of atopic dermatitis.
(4) Subjects who has severe hay fever symptoms.
(5) Subjects who has significant abnormal skin condition at the test site.
(6) Subjects who regularly use intestinal and constipation drugs (including laxatives).
(7) Subjects who has food allergy.
(8) Subjects who drink a large amount of alcohol on a daily basis (more than 60 g of pure alcohol daily for 5 days or more).
(9) Subjects who suffering from Irritable Bowel Syndrome(IBS).
(10) Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation.
(11) Subjects who are judged to be inappropriate as subjects from the answers to the subject background questionnaire.
(12) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
(13) Subjects who has a medical history or current medical history of drug dependence or alcohol dependence.
(14) Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics.
(15) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
NUMANO CLINIC
Division name
Dermatology
Zip code
150-0013
Address
1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
kaco121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales Department
Zip code
105-0023
Address
7F Shibaura Omodaka Bld., 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
MITSUBISHI-CHEMICAL FOODS CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Clinical Research Review Center
Address
2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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
| 2019 | Year | 12 | Month | 18 | 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
45
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 | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 20 | 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 | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044377
