NCT07184905

Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity

Effect of Oral Bifidobacterium Longum on Skin Barrier Dysfunction in Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Oral administration of inactive Bifidobacterium longum group	1×10\^11 CFU of inactive Bifidobacterium longum was given orally once daily for one month
BIOLOGICAL	Oral Bifidobacterium longum group	1×10\^11 CFU of Bifidobacterium longum was given orally once daily for one month

Timeline

• Start date: 2025-09-09
• Primary completion: 2025-10-27
• Completion: 2025-10-31
• First posted: 2025-09-22
• Last updated: 2025-12-03

Locations

1 site across 1 country: China