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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500115816

Enrollment

Unknown

Registered

2025-12-31

Start date

2026-01-05

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious skin diseases

Interventions

The oral trial group of Lactobacillus reuteri:Take 1×10^11 CFU of Lactobacillus reuteri orally once a day for one month.

Inactive Lactobacillus reuteri oral control group:Take 1×10^11 CFU of inactive Lactobacillus reuteri orally once a day for one month.

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Meet the 2020 World Health Organization (WHO) criteria for obesity classification: normal weight: BMI 18.5-24.9 kg/m^2; Overweight: BMI 25-29.9 kg/m^2; Obesity: BMI >= 30 kg/m^2, no duration limitation; 2. Skin barrier damage (such as dry skin, erythema, desquamation, pruritus, etc.); 3. Patients' informed consent and voluntary participation; Signing informed consent; 4. Aged 18-45 years with good general health; 5. Not using drugs that affect the skin barrier (such as hormones and immunosuppressants) within 3 months ", and clearly "allowing the use of drugs for underlying diseases that do not affect the skin (such as antihypertensive drugs and hypoglycemic drugs); 6. No skin disease or trauma.

Exclusion criteria

Exclusion criteria: 1. History of allergy or allergy to probiotics, placebo, or study drug; 2. Patients with active skin disease or other serious diseases; 3. Pregnant or lactating women; 4. Use of drugs that may affect skin barrier function (such as hormone drugs, immunosuppressants, etc.); 5. Other circumstances considered by the investigator to be inappropriate for subject inclusion, such as the subject being untrustworthy, unacceptable, or unable to understand the evaluator of the study.

Design outcomes

Primary

Measure	Time frame
Transepidermal water loss rate of forearm skin;	—

Secondary

Measure	Time frame
Skin hydration;Skin health score;Analysis of the skin microbiota;	—

Countries

China

Contacts

Public ContactJianglin Zhang

Shenzhen People’s Hospital (The First Affiliated Hospital, Southern University of Science and Techno )

zhang.jianglin@szhospital.com+86 138 7314 3466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026