Skip to content

Randomized clinical trial in preventing food allergy Breast feeding vs. breast feeding plus formula milk

Randomized clinical trial in preventing food allergy Breast feeding vs. breast feeding plus formula milk - food allergy prevention trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011577
Enrollment
300
Registered
2013-09-01
Start date
2013-09-01
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

infants high risk for atopic sensitization

Interventions

breast feeding (if amounts of breast milk is not sufficient, elemental formula will be added: max 150ml/day) untill starting solid food breast feeding + formula milk at least 40 ml per day untill star

Sponsors

Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Be in high-risk group of atopic sensitization: at least one of father, mother, brothers and sisters of infants has atopic diseases (asthma, atopic dermatitis, food allergy, allergic rhinitis, hay fever) 2. Obtained informed consent of written form. a. Participants who understand randomization into two groups: breast feeding with or without amino acid milk and breast feeding with ordinal formula milk. b. Blood examination at 5 - 6 months and 2 years of age are requisite. 3. Be available to visit outpatient clinic for 7 times at 1 month, 3 months, 6 months, 9 months, 1 year, 1 and half year, and 2 years of age.

Exclusion criteria

Exclusion criteria: 1. Less than 36 weeks of gestational age or less than 2000g of birth weight. 2. Having serious congenital anomalies. 3. Being triple and more: twins may participate in. 4. Abnormal delivery such as asphyxia (Apgar score 6 and less)

Design outcomes

Primary

MeasureTime frame
atopic sensitization

Secondary

MeasureTime frame
immediate type of food allergy including anaphylaxis worsening of atopic dermatitis desensitization of food allergy atopic sensitization alone asthmatic bronchitis allergic rhinitis

Countries

Japan

Contacts

Public ContactEiko Higuchi

Jikei University School of Medicine Molecular Epidemiology

bunshiekigaku@gmail.com03-3433-1111

Outcome results

None listed

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