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

UMIN ID: UMIN000050668

Registered date:24/03/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Caw's milk allergy
• Date of first enrollment: 2018/01/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 more months of age for 6 months.
Participants were instructed to consume 40 and more ml of hydrolyzed 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 more months of age for 6 months.

Outcome(s)

• Primary Outcome: Changes in soybean skin prick test and soybean-specific IgE antibody titers after 6 months
• Secondary Outcome: Incidence of soybean allergy at 6 months and incidence of adverse events at 6 months

Key inclusion & exclusion criteria

• Age minimum: 2months-old
• Age maximum: 12months-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: National Hospital Organization Sagamihara National Hospital
• Source(s) of Monetary Support: Asahi Group Japan, Ltd.