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This clinical trial aims to evaluate the safety and efficacy of oral Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. The study focuses on the following questions:
Can oral Lactobacillus reuteri supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Lactobacillus reuteri impact skin barrier function and systemic inflammation?
Researchers will compare outcomes across two groups:
Intervention Group (Obese): Oral Lactobacillus reuteri capsules. Placebo Control Group (Obese): Oral inactive (heat-killed) Lactobacillus reuteri.
Participant Procedures:
Take daily oral capsules (Lactobacillus reuteri or inactive strain) for 4 weeks.
Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion.
Provide stool and samples for analyses. Complete weekly check-ins to report adverse effects (e.g., gastrointestinal discomfort, skin irritation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral administration of inactive Lactobacillus reuteri group | Sham Comparator |
| |
| Oral Lactobacillus reuteri group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Lactobacillus reuteri group | Biological | 1×10^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | Mean change from baseline in transepidermal water loss (TEWL) on the volar forearm, measured by Tewameter under standardized conditions, reported in grams per square meter per hour (g/m²/h). | Baseline, 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fecal Genistein Concentration | Mean change from baseline in the concentration of genistein in fecal samples, quantified using LC-MS/MS, reported in micrograms per gram (μg/g) | Baseline, 1 month |
| Change in Skin Microbial Alpha Diversity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianglin Zhang | Contact | +86 13873143466 | zhang.jianglin@szhospital.com | |
| Changzhou Li | Contact | +86 17827062716 |
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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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| Oral administration of inactive Lactobacillus reuteri group | Biological | 1×10^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month |
|
Mean change from baseline in the Shannon Diversity Index of skin microbiota, assessed via 16S rRNA gene sequencing.
| Baseline, 1 month |
| Change in clinical skin health score | Mean change from baseline in the total score of the Skin Dryness Scoring System, reported as a continuous score (0-8, replace with your scale range). | Baseline, 1 month |
| Change in Body Mass Index (BMI) | Mean change from baseline in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared, reported in kg/m². | Baseline, 1 month |
| Change in body weight | Mean change from baseline in total body weight, reported in kilograms (kg). | Baseline, 1 month |