Randomized controlled trial of strategy for prevention of cow's milk allergy by early introduction of cow's milk formula

Randomized controlled trial of strategy for prevention of cow's milk allergy by early introduction of cow's milk formula - Strategy for Prevention of milk Allergy by Daily ingestion of infant formula in Early infancy (SPADE) study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025402

Enrollment

764

Registered

2017-01-01

Start date

2017-01-01

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

Cow&#39

Interventions

Infants of ingesting cow&#39

s milk formula group intake cow&#39

s milk formula at least 10mL daily between 1 month of age to 3 months of age. They ingest cow&#39

s milk formula spontaneously from 4 months of age. They will be performed oral food challenge test at 6 months of age to assess the development of cow&#39

s milk allergy. Infants of eliminating cow&#39

s milk formula group remove cow&#39

s milk formula between 1 month of age to 3 months of age. They ingest cow&#39

s milk allergy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: gestationa age>=35 weeks and birth weight>=2000g

Exclusion criteria

Exclusion criteria: (1)complication of any severe underlying disease (2)may not continue breast feeding

Design outcomes

Primary

Measure	Time frame
The incidence of cow's milk allergy at 6 months of age	—

Secondary

Measure	Time frame
The incidence of cow's milk sesitization and measurement of cow's milk specific IgE and IgG4 titer at 6 months of age	—

Countries

Japan

Contacts

Public ContactTetsuhiro Sakihara

Social medical corporation KARIYUSHIKAI Heartlife Hospital Pediatrics

odekorin2000@yahoo.co.jp098-895-3255

Outcome results

None listed

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

Randomized controlled trial of strategy for prevention of cow&#39;s milk allergy by early introduction of cow&#39;s milk formula