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This clinical trial aims to evaluate the safety and efficacy of topical application of Lactobacillus crispatuson the forearm for treating obesity-induced skin barrier impairment in individuals aged 18-45 with BMI ≥25. The study focuses on the following questions:
Can topical application of Lactobacillus crispatusreduce skin barrier damage, as measured by transepidermal water loss (TEWL), in obese participants?
Does modulation of the skin microbiota with Lactobacillus crispatusimprove skin barrier function, hydration, and reduce local inflammation?
Is the topical intervention safe and well-tolerated, with minimal adverse effects?
Preliminary data from obese volunteers and mouse models revealed significantly elevated TEWL and reduced Lactobacillusabundance in the skin microbiome of obese individuals, supporting the investigation of probiotic restoration.
Researchers will compare outcomes across two groups:
Intervention Group (Obese) : Daily topical application of active Lactobacillus crispatussolution (1×10⁷ CFU in 3 mL) to a 3-cm diameter area on both forearms.
Placebo Control Group (Obese) : Daily topical application of inactivated Lactobacillus crispatussolution (identical appearance and volume).
Participant Procedures:
Apply the assigned topical solution daily to the forearm for 4 weeks.
Undergo non-invasive skin testing, including TEWL measurements and skin hydration assessments, at baseline and study completion (Week 4).
Provide skin swab samples at baseline and Week 4 for microbiome analysis (16S rRNA sequencing) and inflammation marker detection (e.g., IL-1β, TNF-α via ELISA).
Complete weekly check-ins to report adverse effects (e.g., skin irritation, erythema) and adherence, with follow-ups at Weeks 1, 2, and 3.
Maintain a daily electronic or paper diary to record application time, dose, and any skin reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical L. crispatus Treatment Group | Experimental |
| |
| Topical Inactivated Lactobacillus crispatus Application Group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Inactivated Lactobacillus crispatus Application Group | Biological | Once daily, 3mL of inactive Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter | TEWL will be assessed on the volar aspect of the forearm using a Tewameter device under standardized environmental conditions (controlled temperature and humidity). At each time point, TEWL will be measured at three predefined skin sites on the volar forearm, and the average value will be used. The primary outcome will be the mean change in TEWL (g/h/m²) from baseline (Day 0) to 1 month after intervention. Lower TEWL values indicate improved skin barrier function. | Baseline through 1 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin hydration measured by Corneometer | Skin hydration will be assessed using a Corneometer device. Outcomes will be expressed as mean skin capacitance values (arbitrary units) at baseline and post-intervention. | Baseline through 1 month after intervention |
| Change in clinical skin health score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Topical L. crispatus Treatment Group | Biological | Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles |
|
Skin dryness, scaling, erythema, itching, and allergy-related symptoms will be evaluated using a standardized Skin Dryness Scoring System. Data will be reported as mean score change from baseline. |
| Baseline through 1 month after intervention |
| Change in body weight and BMI | Participants' body weight (kg) and BMI (kg/m²) will be recorded at baseline and post-intervention. Data will be reported as mean change. | Baseline through 1 month after intervention |