Capricare^®^ WGF^TM^ shown to protect formula-fed infants from eczema in GIraFFE Study^TM^

A large (n=2132) multi-centre, randomised, double-blind controlled trial of healthy, term, formula-fed infants confirmed that Capricare® WGF can help protect infants from atopic dermatitis (AD)^†^, especially infants with a parental history* of AD^1^.

Formula choice did not affect the rate of eczema diagnosis in all infants when standardised diagnosis criteria were used at only 3 study visits.

Study Measures

• AD_PRIMARY is the primary outcome and the strictest measure. Trained staff use the UKWP diagnostic criteria during face-to-face visits with infants at three time points (4, 6, and 12 months) to assess atopic dermatitis. To diagnose eczema under the UKWP criteria, a child must exhibit itchy skin and at least three of the following symptoms: dry skin, eczema in skin creases, a family history of asthma or hay fever, and visible eczema. Diagnosis based on objective criteria from the UK Working Party (UKWP), capturing only some forms of AD and/or AD present at study visits.
• AD_UKWP includes two additional time points, eight and ten months, where trained staff lead the parents through the UKWP examination of their toddler during a phone call.
• AD_DOCTOR was any AD that was diagnosed by a doctor up to 12 months of age. This captures any occurrence at any time, as evaluated by a trained practitioner, representing normal clinical practice. AD diagnosed by a doctor captures infants developing AD at any time throughout the intervention period.
• AD_ANY combines all the data, representing the total number of infants identified as having AD by one of the measures. Note that an infant diagnosed by two or more methods they are only counted once.

Summary of Results

Study Population

A total of 2,132 infants were recruited and randomly assigned to receive Capricare® WGF(1,065) or CMF (1,067) until 12 months of age. Baseline characteristics were similar between the infants.

• • • Infants born by C-section.
    • Infants with at least one parent who smokes
    • Infants with at least one parent has a history of eczema

Infants are Protected from Atopic Dermatitis when they Continuously Consume WGF for the First Year of Life.

Overall, 327 infants were diagnosed with AD. There was no difference in the incidence of eczema between the WGF and CF groups when AD was measured at 3 study visits (AD_Primary). However, when AD was diagnosed under real-world conditions, there was a significant protective effect of continuous feeding of WGF on infant eczema (AD_Doctor and AD_Any).

• • • Using the UKWP standardised diagnostic criteria for AD, no difference in eczema incidence between the WGF and CF groups was observed in either the ITT or PP populations (AD_Primary and AD_UKWP).
    • Based on clinical practice assessment (AD_Doctor), AD incidence was lower in the WGF group than in the CMF group (21% reduction; trend). A statistically significant 34% reduction was observed in infants who continuously consumed WGF (PP population; p < 0.01).
    • In addition, when all infants assessed by any of the criteria were considered (AD_Any), AD incidence was lower in the WGF group than in the CF group (trend), and a statistically significant reduction was observed in infants who continuously consumed WGF (PP population).

The findings show that AD incidence was lower in the WGF group than in the CMF group. Further, better adherence to WGF, either as part of mixed feeding with breast milk or as the sole source of milk feeding, in the first year of life is associated with a greater reduction in the risk of eczema in babies.

WGF Provides Protection to Infants with a Family History of Eczema

A family history of AD is one of the strongest predictors of AD risk in offspring, increasing the risk by 2-3 times. In the GIraFFE Study, a parental history of doctor-diagnosed AD (at least one parent with a history of AD; high risk infants) was reported in 9.5% of participants.

Among infants with a parental history of AD (high risk), WGF compared with CMF was associated with a strong protective effect across all AD outcomes.

• • When applying the UKWP standardised diagnostic criteria for AD, the incidence of AD was reduced by more than 60% (trend; AD_Primary and AD_UKWP).
  • Based on clinical practice assessment (AD_Doctor), which diagnoses infants at any time during their first year, the incidence of AD was 64% lower in the WGF group than in the CF group (p<0.01). The reduced incidence of AD in the WGF group was also statistically significant when all infants were considered (AD_Any; 61%; p<0.01).
  • A statistically significant reduction of >75% was observed in all measures for infants who consumed WGF (PP population; p < 0.01).

  The protective effect observed in high-risk formula-fed infants is consistent with previous nutrition studies. Evidence from meta-analyses and intervention trials suggests that the benefits of probiotics, and hydrolysed formulas on AD risk are mainly confined to high-risk formula-fed infants.

Severity of AD: Disease severity was similar between groups. Most AD cases were mild to moderate, though a higher proportion of severe AD was observed among infants with a parental history of AD.

Adverse events: AE incidence was similar between groups (2,066 AEs; IRR 1.03, p=0.48).

The GIraFFE Study will follow the infants until 5 years of age to assess the long-term benefits of consuming WGF compared with CF in their first year of life.