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A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of IRT5 probiotics on atopic dermatitis in children

A 8 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of IRT5 probiotics on atopic dermatitis in children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0000914
Enrollment
110
Registered
2013-11-08
Start date
2013-11-06
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Others(IRT 5 probiotics (health functional food)) : treatment group : The main ingredient is IRT5 probiotics, 1 X 100000000000 cfu/sachet, 1 sachet/day. Placebo group : The main ingredient is lactose,

Sponsors

Korea Yakult Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)subject who signs ICF with a legal representative who signs the informed consent form before participating in the study 2)subject aged between 5 years and 12 years with atopic dermatitis 3)subject with intermittent or continuous atopic dermatits symptom over 6 months 4)subject with SCORAD index between 25 and 50

Exclusion criteria

Exclusion criteria: 1)subject with other systemic illnesses or dermatits history except AD 2)subject administrating immunosuppressant,antobiotics,corticosteroid, antihistaminic within 4 weeks 3)subject who has taken medicines,chinese medicine, health functional foods within 4 weeks for improvement of atopic dermatitis 4)subject with systemic phototherapy within 1 month 5)subject with probiotics within 2 weeks 6)subject who has taken scheduled for participating in another study during this study period or who had participated in other study within 4 weeks 7)Inappropriate subject decided by investigator

Design outcomes

Primary

MeasureTime frame
SCORAD (SCORing of Atopic Dermatitis) score

Secondary

MeasureTime frame
immunoglobulin A ;skin condition measurement(moisture, skin oil, skin-ph-meter);eosinophil ;total IgE ;eosinophil cationic protein

Countries

Korea, Republic of

Contacts

Public ContactYu jeong

Chung-Ang Univerisity Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026