Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07512050

Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Skin Barrier to Water Loss Communicable Diseases Disease Attributes Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in Transepidermal Water Loss (TEWL)

    Time frame: 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).

Secondary outcomes

  1. Change in Fecal Genistein Concentration

    Time frame: Baseline, 1 month

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

  2. Change in Skin Microbial Alpha Diversity

    Time frame: Baseline, 1 month

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

  3. Change in clinical skin health score

    Time frame: Baseline, 1 month

    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).

  4. Change in Body Mass Index (BMI)

    Time frame: Baseline, 1 month

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

  5. Change in body weight

    Time frame: Baseline, 1 month

    Mean change from baseline in total body weight, reported in kilograms (kg).

Study contacts

Contact information is provided by the study sponsor or research team.

Changzhou Li

CONTACT

+86 17827062716

Jianglin Zhang

CONTACT

[email protected]

+86 13873143466

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.