Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity

NCT07184905 | Completed

• 1 other identifier: LL-KY-2025110-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Microbial Colonization; Skin Barrier to Water Loss

Outcome Measures

Primary Outcomes (1)

• Mean change in transepidermal water loss (TEWL, g/h/m²) on the volar forearm from baseline to 1 month after intervention, measured by Tewameter

  TEWL will be assessed on the volar aspect of the forearm using a Tewameter device under standardized environmental conditions (controlled temperature and humidity). At each time point, TEWL will be measured at three predefined skin sites on the volar forearm, and the average value will be used. The primary outcome will be the mean change in TEWL (g/h/m²) from baseline (Day 0) to 1 month after intervention. Lower TEWL values indicate improved skin barrier function.

  Baseline through 1 month after intervention

Secondary Outcomes (5)

• Change in gut Bifidobacterium longum abundance and metabolites in fecal samples

  Baseline through 1 month after intervention

• Change in serum inflammatory cytokine levels

  Baseline through 1 month after intervention

• Change in skin hydration measured by Corneometer

  Baseline through 1 month after intervention

• Change in clinical skin health score

  Baseline through 1 month after intervention

• Change in body weight and BMI

  Baseline through 1 month after intervention

Study Arms (2)

Oral administration of inactive Bifidobacterium longum group

SHAM COMPARATOR

Biological: Oral administration of inactive Bifidobacterium longum group

Oral Bifidobacterium longum group

EXPERIMENTAL

Biological: Oral Bifidobacterium longum group

Interventions

Oral administration of inactive Bifidobacterium longum group BIOLOGICAL

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

Oral administration of inactive Bifidobacterium longum group

Oral Bifidobacterium longum group BIOLOGICAL

1×10\^11 CFU of Bifidobacterium longum was given orally once daily for one month

Oral Bifidobacterium longum group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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)
• \. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)
• \. Age 18-40 years
• \. Generally good health (no active systemic diseases)
• \. Able and willing to provide written informed consent
• \. No use of oral/topical medications or probiotics within 6 months prior
• \. No active skin disease or traumatic skin lesions

You may not qualify if:

• \. Known allergy or hypersensitivity to probiotics, placebo, or investigational product
• \. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment
• \. Severe medical conditions:
• a. Cardiopulmonary disease (NYHA class III/IV)
• b. Uncontrolled diabetes (HbA1c \>9%)
• c. Autoimmune disorders
• \. Pregnant or breastfeeding women
• \. 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
• \. Concurrent participation in other interventional trials

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 22, 2025
• Study Start: September 9, 2025
• Primary Completion: October 27, 2025
• Study Completion: October 31, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)