The Melbourne Atopy Cohort Study (MACS): A Randomised controlled trial of a partially hydrolysed whey and a soy formula for the prevention of allergic disease.

In children with a family history of allergic disease does consumption of a partially hydrolysed whey or a soy formula at the cessation or partial cessation of breastfeeding, when compared to conventional cows’ milk formula reduce the incidence of allergic disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000734268

Acronym

MACS

Enrollment

620

Registered

2009-08-25

Start date

1990-01-08

Completion date

1994-07-15

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite a lack of clear evidence, partially hydrolysed whey formula has been recommended at the cessation of exclusive breast-feeding in infants at high risk of developing allergic disease. It is thought that partially hydrolysed whey formula may promote oral tolerance and prevent allergic diseases. Similarly, soy formula has previously been recommended for allergy prevention. The primary aim of this study was to determine if the use of a partially hydrolysed formula, or a soy formula, at the cessation, or partial cessation of breastfeeding, reduced the incidence of allergic manifestations (eczema, urticaria and food reactions), in high-risk infants when compared with a conventional cows’ milk formula.

Interventions

Arm 1: Partially hydrolysed whey formula (Nan HA) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.4g of powdered formula to every 30 ml of warm water. Arm2: Soy formula (Prosobee) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.4g of powdered formula to every 30 ml of warm water

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

Family history of allergic disease (asthma, eczema, allergic rhinitis or severe food allergy)

Exclusion criteria

Nil

Outcome results