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Effect of Oral Bifidobacterium longum on Skin Barrier Dysfunction in Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Effect of Oral Bifidobacterium longum on Skin Barrier Dysfunction in Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105555
Enrollment
Unknown
Registered
2025-07-07
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-14

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

Oral administration of inactive Bifidobacterium longum group (Control group):1×10^11 CFU of inactive Bifidobacterium longum was given orally once daily for one month
Oral Bifidobacterium longum group (Experimental Group):1×10^11 CFU of Bifidobacterium longum was given orally once daily for one month

Sponsors

Shenzhen People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meet WHO 2020 obesity classification standards: Normal weight: BMI 18.5–24.9 kg/m²; Obesity: BMI >= 30 kg/m². 2. Manifestations of skin barrier impairment (e.g., dry skin, erythema, desquamation, pruritus). 3. Informed consent and voluntary participation: Signed informed consent form obtained. 4. Age 18–30 years with generally good health status. 5. No medication or probiotic use within 6 months prior to enrollment. 6. Absence of skin diseases or trauma.

Exclusion criteria

Exclusion criteria: 1. History of allergy or hypersensitivity to probiotics, placebo, or investigational drugs. 2. Active skin diseases or other severe systemic conditions. 3. Pregnancy or lactation. 4. Other conditions deemed by investigators as unsuitable for participation (e.g., unreliable adherence, inability to comprehend study assessments).

Design outcomes

Primary

MeasureTime frame
Transepidermal water loss rate of forearm skin;

Secondary

MeasureTime frame
Skin hydration;Skin health score;

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