UMIN-CTR Clinical Trial

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
Email	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
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044377