Effect of Oral Bifidobacterium Longum on Skin Barrier Dysfunction in Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter
研究概览
简要总结
This clinical trial aims to evaluate the safety and efficacy of oral Bifidobacterium longum supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with BMI ≥30, compared to healthy controls. The study focuses on the following questions:
Can oral Bifidobacterium supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Bifidobacterium longum impact skin barrier function and systemic inflammation?
Researchers will compare outcomes across two groups:
- Intervention Group (Obese): Oral Bifidobacterium longum capsules
- Placebo Control Group (Obese): Oral inactive Bifidobacterium longum (heat-killed)
Participant Procedures:
Take daily oral capsules (Bifidobacterium longum or inactive strain) for 4 weeks Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion Provide blood, stool, and skin swab samples for inflammation and microbiome 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral administration of inactive Bifidobacterium longum group
干预措施: Oral administration of inactive Bifidobacterium longum group (Biological)
Oral Bifidobacterium longum group
干预措施: Oral Bifidobacterium longum group (Biological)
结局指标
主要结局
Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter
时间窗: Baseline through 1 month after intervention
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.
次要结局
- Change in gut Bifidobacterium longum abundance and metabolites in fecal samples(Baseline through 1 month after intervention)
- Change in serum inflammatory cytokine levels(Baseline through 1 month after intervention)
- Change in skin hydration measured by Corneometer(Baseline through 1 month after intervention)
- Change in clinical skin health score(Baseline through 1 month after intervention)
- Change in body weight and BMI(Baseline through 1 month after intervention)