Clinical study to investigate the therapeutic effect of 1-kestose on atopic dermatitis

Phase 2

• Conditions: Atopic dermatitis

• Registration Number: JPRN-UMIN000008858
• Lead Sponsor: Tokai University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-05
• Study Completion: 2014-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1. Users of external corticosteroids that are classified as "very strong" or "stronger" 2. Patients who regularly use probiotics/prebiotics other than 1-kestose for therapeutic purposes 3. Patients who regularly use antibiotics 4. Patients who are judged as ineligible by doctor in charge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity score based on the Severity Scoring of Atopic Dermatitis (SCORAD) 6 weeks after the begining of the administration

Secondary Outcome Measures

Name	Time	Method
1. SCORAD scores 12 weeks after the begining of the administration and 6 weeks after the end of the administration 2. Bifidobacterial count and strain structure, staphylococcus aureus count 3. Permeability test of the intestinal mucosa (lactulose/mannitol load test) 4. Bloot tests (white blood cell count, eosinophil count, immunoglobulin E, ImmunoCAP-ovalbumin/milk/mites, Thymus and Activation-Regulated Chemokine)