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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-

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- - A study for skin condition and intestinal effect by intake of Spore-forming lactic acid bacteria for constipations.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038920
Enrollment
45
Registered
2019-12-18
Start date
2019-12-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult woman with a tendency for constipation.

Interventions

Take 1 capsule of test food(1) with 1 drink of 280 ml, once a day for 8 weeks. Take 1 capsule of test food(2) with 1 drink of 280 ml, once a day for 8 weeks. Take 1 capsule of control food with 1 dri

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales Department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026