Microbial Colonization, Skin Barrier to Water Loss
Conditions
Brief summary
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).
Interventions
BIOLOGICALOral Lactobacillus reuteri group
1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
BIOLOGICALOral administration of inactive Lactobacillus reuteri group
1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
Sponsors
Shenzhen People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Meets 2020 WHO BMI classification: * 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
* 1\. Known allergy or hypersensitivity to probiotics, placebo, or investigational product * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | Baseline, 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Genistein Concentration | Baseline, 1 month | Mean change from baseline in the concentration of genistein in fecal samples, quantified using LC-MS/MS, reported in micrograms per gram (μg/g) |
| Change in Skin Microbial Alpha Diversity | Baseline, 1 month | Mean change from baseline in the Shannon Diversity Index of skin microbiota, assessed via 16S rRNA gene sequencing. |
| Change in clinical skin health score | Baseline, 1 month | 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). |
| Change in Body Mass Index (BMI) | Baseline, 1 month | Mean change from baseline in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared, reported in kg/m². |
| Change in body weight | Baseline, 1 month | Mean change from baseline in total body weight, reported in kilograms (kg). |
Contacts
CONTACTJianglin Zhang
CONTACTChangzhou Li
Outcome results
None listed