Efficacy and Safety of Advanced Fructo-oligosaccharide (FOS) on Atopic Dermatitis: Clinical trial

Not Applicable

Completed

• Conditions: Diseases of the skin and subcutaneous tissue

• Registration Number: KCT0006816
• Lead Sponsor: Samyang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-07-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Patients aged between 24 months and 17 years presenting atopic dermatitis will be enrolled. The diagnosis of atopic dermatitis is based on the criteria defined by Hanifin and Rajka. The criteria included a SCORAD index between 15 and 50.

Exclusion Criteria

1) concomitant other skin diseases except atopic dermatitis or systemic disease
2) administration of systemic corticosteroids or sytemic antibiotics in the previous 1 month
3) administration of immunosuppressant or biologics in the previous 1 month
4) administration of medication for improving atopic dermatitis, herbal medication, probiotics or prebiotics in the previous 1 week
5) administration of antihistamine in the previous 2 weeks
6) administration of fermented milk or intestinal agents at least 4 times a week within 1 week
7) phototherapy in the previous 1 month
8) history of allergies to prebiotics
9) Principal investigator's decision that the patient is impossible to participate in the study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in SCORAD between visit 1 (baseline) and visit 4 (12 weeks)

Secondary Outcome Measures

Name	Time	Method
The difference in mean value of SCORAD between visit 1 (baseline) and visit 4 (12 weeks) ;The difference in objective SCORAD score ;The difference in subjective SCORAD score ;The differences in IGA (Investigator’s Global Assessment);The differences in eosinophil count, ECP and total IgE;The difference in cytokine levels measured in blood;The difference in skin pH, TEWL and corneometer;The difference in skin microbiome profiles;The difference in expression of skin barrier proteins;The difference in amount of TCS and moisturizer used in patients;The difference in gut microbiome profiles;The difference in fecal short chain fatty acid levels