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
- Conditions
- Adult woman with a tendency for constipation.
- Registration Number
- JPRN-UMIN000038920
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 45
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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