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A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy

A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy - A Study on Tolerability and Safety of Soy Formula Use in Infants with Cow's Milk Allergy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050668
Enrollment
40
Registered
2024-03-24
Start date
2018-01-01
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

Caw&#39

Interventions

Participants were instructed to consume 40 and more ml of soy formula per day 3 and more times per week for less than 7 months of age, and 80 and more ml per day 3 and more times per week for 7 and mo

Sponsors

National Hospital Organization Sagamihara National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The infants who eliminated cow's milk due to a diagnosis or suspicion of immediate-type cow's milk allergy and whose blood tests showed soybean-specific IgE level was less than 0.35 kUA/L

Exclusion criteria

Exclusion criteria: Preterm infants, renal-impaired infants, congenital hypothyroid infants, or infants who were already consuming adequate amounts of regular milk or dairy products, or soy formula were excluded.

Design outcomes

Primary

MeasureTime frame
Changes in soybean skin prick test and soybean-specific IgE antibody titers after 6 months—

Secondary

MeasureTime frame
Incidence of soybean allergy at 6 months and incidence of adverse events at 6 months—

Countries

Japan

Contacts

Public ContactNaoko Fusayasu

National Hospital Organization Sagamihara National Hospital Clinical Research Center for Allergy and Rheumatology

nen19842000@yahoo.co.jp042-742-8311

Outcome results

None listed

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