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A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on protecting the skin from UV damage.

A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on protecting the skin from UV damage. - A study of the effects of probiotics on protecting the skin from UV damage.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059125
Enrollment
110
Registered
2025-09-18
Start date
2025-09-29
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

None

Interventions

Sponsors

DRC Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participants aged 30 to 59 years at the time of obtaining consent. 2) Participants whose Fitzpatrick skin phototype is type II or III. 3) Participants whose dorsal skin allows for the evaluation of minimum erythema dose (MED), and who were judged to have MED in the second to sixth levels of UV radiation at the screening. 4) Participants who are able to visit the test site on all test days.

Exclusion criteria

Exclusion criteria: 1) Participants with photosensitivity disorder. 2) Participants taking medicines affecting the skin sensitivity to light. 3) Participants continuously taking anti-inflammatory medicines at least once a month. 4) Participants undergoing cosmetic treatments affecting the skin, or potent cosmetics. 5) Participants habitually consuming items affecting the skin. 6) Participants with skin conditions or damage, including scars, inflammation or regular skin irritation on their dorsal skin, such as pre/post menstruation. 7) Participants who have been exposed to UV rays beyond daily life during the two months prior to the screening, or cannot refrain from excessive UV exposure during the study period. 8) Participants with serious drug/food allergies or a history of them. 9) Participants currently under treatment or with a history of serious symptoms from malignant tumors or disorders of respiratory, liver, kidney, heart, lung, digestive, blood, endocrine, or metabolic systems. 10) Participants habitually consuming items with lactobacilli, bifidobacteria, oligosaccharides or affecting the intestinal environment. 11) Participants habitually drinking excessive alcohol. 12) Participants with a smoking habit. 13) Participants with a BMI under 17.0 kg/m2 or 28.0 kg/m2 or more. 14) Participants with fewer than three bowel movements per week. 15) Participants with chronic gastrointestinal symptoms such as diarrhea. 16) Participants with irregular lifestyles. 17) Participants planning lifestyle changes, or visit areas with strong UV rays during the study period. 18) Participants who are pregnant, breastfeeding, or planning pregnancy during the study period. 19) Participants who have participated in other studies three months prior to the date of consent, scheduled to participate in studies, or have traces of sunburn on the dorsal skin from previous studies. 20) Participants judged ineligible by principal investigator based on their background.

Design outcomes

Primary

MeasureTime frame
Minimal erythema dose (MED)

Secondary

MeasureTime frame
Skin color (a*)

Countries

Japan

Contacts

Public ContactYuhma Yoshida

DRC Co., Ltd. Efficacy Testing of Cosmetics and Foods Group

yoshida@drc-web.co.jp06-6882-8201

Outcome results

None listed

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