A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Oral Lactobacillus Reuteri in Treating Skin Barrier Function Impairment Caused by Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Change in Transepidermal Water Loss (TEWL)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral administration of inactive Lactobacillus reuteri group
干预措施: Oral administration of inactive Lactobacillus reuteri group (Biological)
Oral Lactobacillus reuteri group
干预措施: Oral Lactobacillus reuteri group (Biological)
结局指标
主要结局
Change in Transepidermal Water Loss (TEWL)
时间窗: 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).
次要结局
- Change in Fecal Genistein Concentration(Baseline, 1 month)
- Change in Skin Microbial Alpha Diversity(Baseline, 1 month)
- Change in clinical skin health score(Baseline, 1 month)
- Change in Body Mass Index (BMI)(Baseline, 1 month)
- Change in body weight(Baseline, 1 month)