NCT07512050

Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Oral Lactobacillus Reuteri in Treating Skin Barrier Function Impairment Caused by Obesity.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• 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 Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. The study focuses on the following questions: Can oral Lactobacillus reuteri supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Lactobacillus reuteri impact skin barrier function and systemic inflammation? Researchers will compare outcomes across two groups: Intervention Group (Obese): Oral Lactobacillus reuteri capsules. Placebo Control Group (Obese): Oral inactive (heat-killed) Lactobacillus reuteri. Participant Procedures: Take daily oral capsules (Lactobacillus reuteri or inactive strain) for 4 weeks. Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion. Provide stool and samples for 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 Lactobacillus reuteri group	1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month
BIOLOGICAL	Oral administration of inactive Lactobacillus reuteri group	1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month

Timeline

• Start date: 2026-04-10
• Primary completion: 2026-06-28
• Completion: 2026-07-30
• First posted: 2026-04-06
• Last updated: 2026-04-06