Menu
Not yet recruiting NCT07512050

Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity

No phase Interventional Skin Barrier to Water Loss Microbial Colonization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Lactobacillus reuteri group, Oral administration of inactive Lactobacillus reuteri group.
Who it may be relevant to
Registry conditions: Skin Barrier to Water Loss, Microbial Colonization. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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).

Interventions

  • 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

Primary outcome measures

  • Change in Transepidermal Water Loss (TEWL) [Time frame: Baseline, 1 month]
Secondary outcome measures (5)
  • Change in Fecal Genistein Concentration [Time frame: Baseline, 1 month]
  • Change in Skin Microbial Alpha Diversity [Time frame: Baseline, 1 month]
  • Change in clinical skin health score [Time frame: Baseline, 1 month]
  • Change in Body Mass Index (BMI) [Time frame: Baseline, 1 month]
  • Change in body weight [Time frame: Baseline, 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07512050 · LL-KY-2025272-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗