Topical Lactobacillus Crispatus for Skin Barrier Dysfunction in Obesity
NCT ID: NCT07266532
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2025-12-15
2025-12-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Topical L. crispatus Treatment Group
Topical L. crispatus Treatment Group
Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
Topical Inactivated Lactobacillus crispatus Application Group
Topical Inactivated Lactobacillus crispatus Application Group
Once daily, 3mL of inactive Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
Interventions
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Topical Inactivated Lactobacillus crispatus Application Group
Once daily, 3mL of inactive Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
Topical L. crispatus Treatment Group
Once daily, 3mL of Lactobacillus crispatus solution was applied to the bilateral forearms at a diameter of 3cm 10cm from the carpal wrinkles
Eligibility Criteria
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Inclusion Criteria
* a. Normal weight (18.5-24.9 kg/m²)
* b. Overweight (25-29.9 kg/m²)
* c. Obesity (≥30 kg/m²)
* 2\. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
* 3\. Age 18-40 years
* 4\. Generally good health (no active systemic diseases)
* 5\. Able and willing to provide written informed consent
* 6\. No use of oral/topical medications or probiotics within 6 months prior
* 7\. No active skin disease or traumatic skin lesions
Exclusion Criteria
* 2\. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
* 3\. Severe medical conditions:
* a. Cardiopulmonary disease (NYHA class III/IV)
* b. Uncontrolled diabetes (HbA1c \>9%)
* c. Autoimmune disorders
* 4\. Pregnant or breastfeeding women
* 5\. Any condition that may interfere with protocol compliance (per investigator judgement), including:
* a. Inability to understand study procedures
* b. History of poor clinical trial adherence
* 6\. Concurrent participation in other interventional trials
18 Years
40 Years
ALL
Yes
Sponsors
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Shenzhen People's Hospital
OTHER
Responsible Party
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Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Countries
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Other Identifiers
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LL-KY-2025229-02
Identifier Type: -
Identifier Source: org_study_id