Health TrialsbyHealthPanel

Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity

ConditionsSkin Barrier to Water LossMicrobial Colonization
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Oral Lactobacillus reuteri group

    Biological/Vaccine

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

  • Oral administration of inactive Lactobacillus reuteri group

    Biological/Vaccine

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Oral administration of inactive Lactobacillus reuteri groupSham comparator 1 intervention
Group B: Oral Lactobacillus reuteri groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Transepidermal Water Loss (TEWL)

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).

Time frame
Baseline, 1 month

Secondary outcomes

1

Change in Fecal Genistein Concentration

Mean change from baseline in the concentration of genistein in fecal samples, quantified using LC-MS/MS, reported in micrograms per gram (μg/g)

Time frame
Baseline, 1 month
2

Change in Skin Microbial Alpha Diversity

Mean change from baseline in the Shannon Diversity Index of skin microbiota, assessed via 16S rRNA gene sequencing.

Time frame
Baseline, 1 month
3

Change in clinical skin health score

Mean change from baseline in the total score of the Skin Dryness Scoring System, reported as a continuous score (0-8, replace with your scale range).

Time frame
Baseline, 1 month
4

Change in Body Mass Index (BMI)

Mean change from baseline in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared, reported in kg/m².

Time frame
Baseline, 1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: