UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046242 |
|---|---|
| Receipt number | R000052747 |
| Scientific Title | Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/12/02 09:28:31 |
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Basic information
Public title
Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition
Acronym
Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition
Scientific Title
Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition
Scientific Title:Acronym
Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of lactic acid bacteria-containing foods on skin condition and inflammation-related markers during 8 weeks of continuous intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin measurement (stratum corneum water content, transepidermal water loss, color difference (a *, L *))
QOL questionnaire (SKINDEX16, DLQI, SF-36, VAS questionnaire)
Evaluate before, 4 weeks and 8 weeks after intake.
Key secondary outcomes
Inflammation-related markers
Evaluate before, 4 weeks and 8 weeks after intake.
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
2 grains of the test product daily oral intake for 8 weeks.
Interventions/Control_2
2 grains of the placebo daily oral intake for 8 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
Male and Female
Key inclusion criteria
(1) Men and women between the ages of 20 and 64.
(2) Subjects who are aware of itching due to dry skin.
(3) Subjects who are judged by a doctor that treatment for atopic dermatitis is not necessary.
(4) Subjects who fall under any one or more of the following atopic predispositions
A: Relatives or subjects fall under any of the following
ï½¥Relatives (within 3rd degree) have a history of or are currently suffering from bronchial asthma, allergic rhinitis, conjunctivitis, atopic dermatitis, or more.
ï½¥Subject has a history of bronchial asthma, allergic rhinitis, conjunctivitis, atopic dermatitis, or more than one, and is not currently receiving treatment.
B: Easy to produce IgE antibody
Key exclusion criteria
(1) Subjects who regularly use foods rich in lactic acid bacteria, health foods, and medicines at least three times a week.
(2) Subjects who routinely take health foods that may affect the test results.
(3) Subjects with experience in aesthetic medicine that affect the measurement site.
(4) Subjects who received aesthetic medicine or hormone replacement therapy other than the measurement site from one year ago.
(5) Subjects who have undergone esthetic treatment, scrubbing, or hair loss on the skin at the measurement site from one month ago to the end of the study.
(6) Subjects who plan to get a sunburn due to long hours of outdoor work, etc. from one month ago to the end of the study.
(7) Subjects who have a habit of washing their bodies by giving a strong stimulus to the measurement site.
(8) Subjects who regularly use bath salts or subjects who have a habit of taking a hot spring at a frequency of 1 day or more a month.
(9) Subjects with skin disorders at the measurement site.
(10) Subjects who feel that rough skin occurs at the measurement site before and after menstruation.
(11) Night and day shift worker.
(12) Subjects who plan to travel abroad during the research period.
(13) Subjects who have serious diseases, or diseases that affect the secretion of sex hormones, or have a history thereof.
(14) Subjects who may develop allergic-like symptoms with research foods.
(15) Subjects with a disease under treatment that affects the evaluation of this study, or with a history of serious illness.
(16) Subjects whose pre-examination test values are significantly out of the reference range.
(17) Subjects who have participated in other clinical studies within one month or will participate in.
(18) Subjects who are planned to become pregnant 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.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corporation Kenshokai Fukushima Healthcare Center
Division name
Head
Zip code
553-0004
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka-shi, Osaka
TEL
06-6441-6848
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
| 2021 | Year | 12 | Month | 01 | 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
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052747
