NCT07512050Not yet recruiting
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.
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 10 Apr 2026
- Primary completion date
- 28 Jun 2026
- Lead sponsor
- Shenzhen People's Hospital
- Diseases
- Obesity
- NCT number
- NCT07512050
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 10 Apr 2026 to the primary completion date, 28 Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 6\. Concurrent participation in other interventional trials
Other illness
- 2\. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3\. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- c. Autoimmune disorders
- 5\. Any condition that may interfere with protocol compliance (per investigator judgement), including:
- b. History of poor clinical trial adherence
Lab values
- b. Uncontrolled diabetes (HbA1c \>9%)
Other
- 4\. Pregnant or breastfeeding women
- a. Inability to understand study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.