Clinical trial

Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity

Opening soon · Not applicable · 0 countries · Registry ID NCT07512050

Opening soonNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexAll

Healthy volunteersAccepted

ConditionSkin Barrier to Water Loss, Microbial Colonization

Full registry 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

Treatments and study arms

Oral Lactobacillus reuteri group

Biological

1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month

Oral administration of inactive Lactobacillus reuteri group

Biological

1×10\^11 CFU of inactive Lactobacillus reuteri was given orally once daily for one month

Primary outcomes

Change in Transepidermal Water Loss (TEWL)Baseline, 1 month

Mean change from baseline in transepidermal water loss (TEWL) on the volar forearm, measured by Tewameter under standardized conditions, reported in grams per square meter per hour (g/m²/h).

Study locations

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No public site location was included in this record. Check the original registry for updates.