An interventional study of Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap in Atopic Dermatitis (Eczema), sponsored by Codex Labs Corporation. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Codex Labs Corporation · Not applicable, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Codex Labs Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Local EASI score of 0-15:
Exclusion Criteria:
The participant is provided with and instructed to use an oral prebiotic supplement and an oral synbiotic supplement for the duration of the study. In addition, the participant is also provided with and instructed to use a topical lotion to use in replacement of of the participants usual moisturizing product and an unscented soap, in replacement of the participant's usual cleansing product for the duration of the study.
Other: Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap
The intervention includes 4 products: 1. An oral prebiotic dietary supplement 2. An oral synbiotic dietary supplement 3. A topical lotion 4. An unscented bar of soap
Objective and Subjective Scoring of Eczema Severity
Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C
Time frame: 8 weeks
Localized Eczema Severity
Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.
Time frame: 8 weeks
Objective and Subjective Scoring of Eczema Severity
Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C
Time frame: 4 weeks
Localized Eczema Severity
Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.
Time frame: 4 weeks
Skin Hydration
Change in skin hydration is assessed with a Corneometer.
Time frame: 4 weeks
Skin Hydration
Change in skin hydration is assessed with a Corneometer.
Time frame: 8 weeks
Transepidermal Water Loss
Change in transepidermal water loss is assessed with a Tewameter TM 300
Time frame: 4 weeks
Transepidermal Water Loss
Change in transepidermal water loss is assessed with a Tewameter TM 300
Time frame: 8 weeks
Desquamation Index
Change in desquamation is assessed with D-Squam®.
Time frame: 4 weeks
Desquamation Index
Change in desquamation is assessed with D-Squam®.
Time frame: 8 weeks
Positive and Negative Affect
Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form). Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.
Time frame: 4 weeks
Positive and Negative Affect
Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form). Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.
Time frame: 8 weeks
Plan to share: No — Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.
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This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Codex Labs Corporation