Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorShenzhen People's Hospital
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
1. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
2. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
a. Cardiopulmonary disease (NYHA class III/IV)
b. Uncontrolled diabetes (HbA1c >9%)
Trial design
Treatments tested in this trial
- Oral Lactobacillus reuteri group
- Oral administration of inactive Lactobacillus reuteri group
Treatment groups
140 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov