Kestose Intake for prevention of atopic dermatitis in Tokyo

JRCT ID: jRCTs031220020

Registered date:13/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 13/04/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Kestose group
-In the neonatal period (from the start of the interventionto 30 days of age), ingestion of kestose 0.3 g/dose
three times a day (0.9 g/day).
-From 31 days of age to 20 weeks of age (until the assessment of the primary endpoint), ingestion of kestose 0.5 g/dose twice daily (1.0 g/day).
Maltose group
-In the neonatal period (from the start of the intervention until 30 days of age), ingestion of maltose 0.3 g/dose 3 times a day (0.9 g/day).
-From 31 days of age to 20 weeks of age (until the assessment of the primary endpoint), ingestion of maltose 0.5 g/dose twice daily (1.0 g/day).

Outcome(s)

• Primary Outcome: Incidence of atopic dermatitis up to 20 weeks of age

Secondary Outcome

1)Disease-free period for topic dermatitis
2) EASI score at diagnosis of atopic dermatitis
3) POEM score at diagnosis of atopic dermatitis
4) Horny water content (SCH) and transepidermal water loss (TEWL)
5) Incidence of expiratory wheezing up to 20 weeks of age
6) Incidence of physician-diagnosed food allergy up to 20 weeks of age
7) Total IgE antibody titre, specific IgE antibody titre
8) Treg measurements
9) Serum SCCA2 level
10) Stool examination for intestinal microflora
11) Stool characteristics and defecation status

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 1weeks old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Saito Mayako
• Source(s) of Monetary Support: Natural Science Co.Ltd.