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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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral administration of inactive Bifidobacterium longum group | Sham Comparator |
| |
| Oral Bifidobacterium longum group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral administration of inactive Bifidobacterium longum group | Biological | 1×10^11 CFU of inactive Bifidobacterium longum was given orally once daily for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter | 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. | Baseline through 1 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut Bifidobacterium longum abundance and metabolites in fecal samples | Stool samples will be collected at baseline and after intervention. Microbial abundance will be assessed by 16S rRNA sequencing, and metabolites will be profiled using targeted metabolomics. Data will be reported as relative abundance (%) and metabolite concentrations (µM). | Baseline through 1 month after intervention |
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Inclusion Criteria :
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
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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 Bifidobacterium longum group | Biological | 1×10^11 CFU of Bifidobacterium longum was given orally once daily for one month |
|
| Change in serum inflammatory cytokine levels | Serum samples will be collected before and after Bifidobacterium longum treatment. Cytokine levels (e.g., IL-6, TNF-α, IL-22) will be measured by ELISA, reported as pg/mL. | Baseline through 1 month after intervention |
| Change in skin hydration measured by Corneometer | Skin hydration will be assessed using a Corneometer device. Outcomes will be expressed as mean skin capacitance values (arbitrary units) at baseline and post-intervention. | Baseline through 1 month after intervention |
| Change in clinical skin health score | Skin dryness, scaling, erythema, itching, and allergy-related symptoms will be evaluated using a standardized Skin Dryness Scoring System. Data will be reported as mean score change from baseline. | Baseline through 1 month after intervention |
| Change in body weight and BMI | Participants' body weight (kg) and BMI (kg/m²) will be recorded at baseline and post-intervention. Data will be reported as mean change. | Baseline through 1 month after intervention |