Randomized controlled trial of intake of milk in infancy by high-risk infants to prevent milk allergy

Randomized controlled trial of intake of milk in infancy by high-risk infants to prevent milk allergy - Prevention of infants' milk allergy (PIMA study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030214

Enrollment

128

Registered

2017-12-01

Start date

2017-12-01

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

Food allergy

Interventions

Perform a 3 ml heated milk OFC among those aged 6 to 11 months old. If the OFC is negative, the patients take 3 ml of milk at home regularly until the next OFC. Eliminate milk completely until 18 mon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Sensitized to milk Food allergy other than milk (for example, egg, wheat, and soy)

Exclusion criteria

Exclusion criteria: History of immediate symptoms after consuming milk. Regular intake of more than 3 ml of milk before initiation of the trial Non-IgE mediated gastrointestinal food allergy after consuming milk Severe (uncontrolled) atopic dermatis before initiation of the trial

Design outcomes

Primary

Measure	Time frame
Proportion of patients who developed an immediate type milk allergy by the age of 2 years (Positive rate of intake of 3 ml or 25 ml of heated milk oral food challenge test)	—

Secondary

Measure	Time frame
Proportion of patients who could take 50 ml of unheated milk by the age of 3 years Severity of each oral food challenge test Prognosis of other food allergies	—

Countries

Japan

Contacts

Public ContactKiyotake Ogura

National Hospital Organization Sagamihara National Hospital Department of Pediatrics

ogura.kiyotake.yg@mail.hosp.go.jp042-742-8311

Outcome results

None listed

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