NCT07184905Completed
Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity
Effect of Oral Bifidobacterium Longum on Skin Barrier Dysfunction in Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
This clinical trial aims to evaluate the safety and efficacy of oral Bifidobacterium longum supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with BMI ≥30, compared to healthy controls. The study focuses on the following questions: Can oral Bifidobacterium supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Bifidobacterium longum impact skin barrier function and systemic inflammation? Researchers will compare outcomes across two groups: * Intervention Group (Obese): Oral Bifidobacterium longum capsules * Placebo Control Group (Obese): Oral inactive Bifidobacterium longum (heat-killed) Participant Procedures: Take daily oral capsules (Bifidobacterium longum or inactive strain) for 4 weeks Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion Provide blood, stool, and skin swab samples for inflammation and microbiome analyses Complete weekly check-ins to report adverse effects (e.g., gastrointestinal discomfort, skin irritation)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 6 Aug 2025
- Start date
- 9 Sept 2025
- Primary completion date
- 27 Oct 2025
- Lead sponsor
- Shenzhen People's Hospital
- Diseases
- Obesity
- NCT number
- NCT07184905
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 9 Sept 2025 to the primary completion date, 27 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
- 6\. Concurrent participation in other interventional trials
Other illness
- 2\. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
- 3\. Severe medical conditions:
- a. Cardiopulmonary disease (NYHA class III/IV)
- c. Autoimmune disorders
- 5\. Any condition that may interfere with protocol compliance (per investigator judgement), including:
- b. History of poor clinical trial adherence
Lab values
- b. Uncontrolled diabetes (HbA1c \>9%)
Other
- 4\. Pregnant or breastfeeding women
- a. Inability to understand study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.