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

Efficacy and Safety of Advanced Fructo-oligosaccharide (FOS) on Atopic Dermatitis; A Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006816

Enrollment

Registered

2021-12-07

Start date

2021-05-18

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : As a randomized, double-blind, control food controlled human application test, the allocation ratio of each group is set as test group: control group = 1:1. Patients will be given either adva

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The change in SCORAD between visit 1 (baseline) and visit 4 (12 weeks)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactYeonghee Kim

Samsung Medical Center

salutavrillee@naver.com+82-2-3410-0312

Outcome results