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 range
18 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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