Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059125) titled 'A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on protecting the skin from UV damage' on Sept. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - DRC Co., Ltd.
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous probiotic ingestion in protecting skin from UV damage in healthy adults.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of test foods for 8 weeks.
Interventions/Control_2 - Intake of placebo foods for 8 weeks.
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key 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.
Key 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.
Target Size - 110
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 04 Day
Date of IRB - 2025 Year 09 Month 04 Day
Anticipated trial start date - 2025 Year 09 Month 29 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067632
Disclaimer: Curated by HT Syndication.
