Status:
COMPLETED
Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity
Lead Sponsor:
Shenzhen People's Hospital
Conditions:
Skin Barrier to Water Loss
Microbial Colonization
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07184905
Start Date
September 9 2025
End Date
October 31 2025
Last Update
December 3 2025
Active Locations (1)
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1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020