Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity

Southern University of Science and Technology

Status

Completed

Conditions

Microbial Colonization

Skin Barrier to Water Loss

Treatments

Biological: Oral administration of inactive Bifidobacterium longum group

Biological: Oral Bifidobacterium longum group

Study type

Interventional

Funder types

Other

Identifiers

NCT07184905

LL-KY-2025110-02

Details and patient eligibility

About

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)

Enrollment

140 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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