The Effects of an Oral Prebiotic and an Oral Synbiotic Supplement in Combination With a Topical L… (NCT07041892) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effects of an Oral Prebiotic and an Oral Synbiotic Supplement in Combination With a Topical Lotion and Soap On Eczema
Poland34 participantsStarted 2025-04-04
Plain-language summary
The purpose of this study is to examine the effects of 2 dietary supplements (an oral prebiotic and an oral synbiotic) in combination with a topical lotion, and an unscented soap on eczema severity, various skin measures (such as skin hydration), and mood in those with eczema.
A prebiotic supplement contains ingredients that can get broken down by the bacteria in the gut.
A synbiotic supplement contains prebiotic and probiotic ingredients.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sex: female and male;
* Age : 18 years old and above;
* Phototype: I to IV;
* Type: Caucasian;
* Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);
* Subjects with a SCORAD of 25 - 50;
* Local EASI score of 0-15:
* 30% - 4-5
* 30%- 6-7
* 30% - 8-9
* Subjects with dry and very dry skin on the study areas (cutaneous hydration rate \< 50 A.U);
* Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;
* No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;
* Subjects agreeing not to change lifestyle habits during the study duration
* Healthy subject;
* Subject having given her free informed, written consent;
* Subject willing to adhere to the protocol and study procedures;
* Subject with Polish citizenship.
Exclusion Criteria:
* For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;
* Cutaneous pathology on the study zone (other than eczema);
* Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications …
What they're measuring
1
Objective and Subjective Scoring of Eczema Severity
Timeframe: 8 weeks
2
Localized Eczema Severity
Timeframe: 8 weeks
3
Objective and Subjective Scoring of Eczema Severity