Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity

NCT ID: NCT07184905

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2025-10-31

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, 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)

Conditions

Skin Barrier to Water Loss; Microbial Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oral administration of inactive Bifidobacterium longum group

Group Type: SHAM_COMPARATOR

Oral administration of inactive Bifidobacterium longum group

Intervention Type: BIOLOGICAL

1×10\^11 CFU of inactive Bifidobacterium longum was given orally once daily for one month

Oral Bifidobacterium longum group

Group Type: EXPERIMENTAL

Oral Bifidobacterium longum group

Intervention Type: BIOLOGICAL

1×10\^11 CFU of Bifidobacterium longum was given orally once daily for one month

Interventions

Oral administration of inactive Bifidobacterium longum group

1×10\^11 CFU of inactive Bifidobacterium longum was given orally once daily for one month

Intervention Type: BIOLOGICAL

Oral Bifidobacterium longum group

1×10\^11 CFU of Bifidobacterium longum was given orally once daily for one month

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

LL-KY-2025110-02

Identifier Type: -

Identifier Source: org_study_id