Kestose Intake for prevention of atopic dermatitis in Tokyo
- Conditions
- atopic dermatitisD003876
- Registration Number
- JPRN-jRCTs031220020
- Lead Sponsor
- Saito Mayako
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) At the time of obtaining the consent,the newborn was less than 6 days old
2) A newborn with at least one parent of sibling who has had atopic dermatitis(high-risk newborn)
3) Newborn infants whose parents have given written informed consent after receiving the explanation
1) Newborn infants who has already has atopic dermatitis
2) Newborn infants using topical drug s such as steroids (excluding the topical and anal areas )
3) Newborn infants with skin lesions such as abnormal keratinization and bullous disease
4) Newborn born less than 37 weeks in g estation
5) Newborn born by cesarean section
6) Multiple fetuses
7) Newborn with serious complications
8) If they plan to move during the study period and may not be able to visit the research facility
9) If the applicant cannot understand Japanese
10) In addition, if the investig ator judg es it inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of atopic dermatitis up to 20 weeks of age
- Secondary Outcome Measures
Name Time Method 1)Disease-free period for topic dermatitis<br>2) EASI score at diagnosis of atopic dermatitis<br>3) POEM score at diagnosis of atopic dermatitis<br>4) Horny water content (SCH) and transepidermal water loss (TEWL)<br>5) Incidence of expiratory wheezing up to 20 weeks of age<br>6) Incidence of physician-diagnosed food allergy up to 20 weeks of age<br>7) Total IgE antibody titre, specific IgE antibody titre<br>8) Treg measurements<br>9) Serum SCCA2 level<br>10) Stool examination for intestinal microflora<br>11) Stool characteristics and defecation status