Kestose Intake for prevention of atopic dermatitis in Tokyo

Effective prevention of atopic dermatitis by ingesting kestose compared to maltose in high-risk neonates A sing le center, randomized, blinded, parallel, 2 group, phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220020

Enrollment

100

Registered

2022-04-13

Start date

2022-07-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

atopic dermatitis

Interventions

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 (un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Incidence of atopic dermatitis up to 20 weeks of age	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactKiwako Yamamoto

National Center for Child Health and Development

mayaa_356@hotmail.com+81-3-3416-0611

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026