Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT07184905
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2025-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Bifidobacterium Longum for Skin Barrier Dysfunction in Obesity
Sponsor:
Shenzhen People's Hospital
Organization:
Study Overview
Official Title:
Effect of Oral Bifidobacterium Longum on Skin Barrier Dysfunction in Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: