MedTrace Logo

Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity

NCT07184905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-03

No results posted yet for this study

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

  • Skin Barrier to Water Loss
  • Microbial Colonization

Interventions

BIOLOGICAL

Oral administration of inactive Bifidobacterium longum group

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

BIOLOGICAL

Oral Bifidobacterium longum group

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

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2025-10-27
Completion
2025-10-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07184905 on ClinicalTrials.gov