Comparison of a partially hydrolyzed infant formula with two extensively hydrolyzed formulas for allergy prevention:A prospective, randomized study

Abstract

The aim of this study was to compare the allergy-preventive effect of a partially hydrolyzed formula with two extensively hydrolyzed formulas, in infants with a high risk for development of allergic disease. High-risk infants from four Danish centres were included in the period from June 1994 to July 1995. Five-hundred and ninety-five high-risk infants were identified. High-risk infants were defined as having biparental atopy, or a single atopic first-degree relative combined with cord blood immunoglobulin E (IgE)> or =0.3 kU/l. At birth all infants were randomized to one of three different blinded formulas. All mothers had unrestricted diets during pregnancy and lactation and were encouraged to breast-feed exclusively. If breast-feeding was insufficient, one of the three formulas, according to randomization, was given during the first 4 months. It was recommended not to introduce cow's milk, cow's milk products. and solid foods until the age of 4 months. After the age of 4 months a normal unrestricted diet and conventional cow's milk-based formula were given when needed. All infants were followed-up prospectively with interview and physical examination at the age of 6, 12, and 18 months, and if any possible atopic symptoms were reported. If food allergy was suspected, controlled elimination/challenge procedures were performed in a hospital setting. Of 550 infants included in the study, 514 were seen at all visits and 36 were excluded owing to noncompliance. Of 478 infants who completed the study, 232 were exclusively breast-fed, 79 received an extensively hydrolyzed casein formula (Nutramigen), 82 an extensively hydrolyzed whey formula (Profylac), and 85 a partially hydrolyzed whey formula (Nan HA), during the first 4 months of life. These four groups were identical in regard to atopic predisposition, cord blood IgE, birthplace, and gender. Exclusively breast-fed children were exposed less to tobacco smoke and pets at home and belonged to higher social classes, whereas the three formula groups were identical concerning environmental factors. The frequency of breast-feeding was high; only eight (2%) children were not breast-fed at all. The three formula groups were identical in regard to duration of breast-feeding and age at introduction of formula and solid foods. No significant differences were found in the three groups of infants receiving formula milk regarding the cumulative incidence of atopic dermatitis or respiratory symptoms. The cumulative incidence of parental-reported cow's milk allergy was significantly higher in children fed partially hydrolyzed formula (Nan HA) compared with extensively hydrolyzed formula (Nutramigen or Profylac) at 12 and 18 months (NanHA, 7.1%; Nutramigen, 2.5%; Profylac, 0%; p=0.033). The cumulative incidence of confirmed cow's milk allergy was 1.3% (three of 232) in exclusively breast-fed infants, 0.6% (one of 161) in infants fed extensively hydrolyzed formula (Nutramigen or Profylac), and 4.7%(four of 85) in infants fed partially hydrolyzed formula (Nan HA). Partially hydrolyz...

Allergic manifestation 15 years after early intervention with hydrolyzed formulas – theGINIStudy

“…As 80–90% of respiratory allergic diseases in children and young adolescents are associated with sensitization to aeroallergens (mainly pollen and house dust mites), it is reasonable to hypothesize that IgE might be involved. However, we did not observe any association between specific IgE measured in serum and hydrolyzates at 15 years, which is consistent with our findings at six and ten years 21, 27 and with reports from the literature 17, 18, 19. Therefore, IgE does not appear to be involved in the observed findings in this study.…”

“…Most 11, 12, 13, 14, 15, 16, 17, 18, 19 but not all 7 randomized, controlled trials that have compared different partially and/or extensively hydrolyzed formulas with standard cow′s milk formula (CMF) have confirmed some degree of preventative effect on allergies in the first 2–3 years of life. Results appear especially consistent for eczema 20 within the first year of life.…”

Prebiotic‐supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high‐risk infants: a randomized controlled trial

“…Sample size: a reduction in cumulative incidence of eczema from 30% to 20% at 12 months was considered clinically relevant 17, 18, 19. Assuming 15% dropout, this study required 350 infants randomized before 4 weeks in each arm, to have 80% power to detect this reduction in eczema, using two‐tailed chi‐squared test at a significance of 0.05.…”

Effects of Early Nutritional Interventions on the Development of Atopic Disease in Infants and Children: The Role of Maternal Dietary Restriction, Breastfeeding, Timing of Introduction of Complementary Foods, and Hydrolyzed Formulas

“…49,51,52 Two of these studies found no significant effect, 51,52 and a third study found an OR of 0.45 (95% CI: 0.22-0.94) for partially hydrolyzed formula versus cow milk formula. 49 Three more studies [53][54][55] examined prolonged feeding of extensively hydrolyzed formula compared with partially hydrolyzed formula in 411 infants at high risk of developing allergy. None of these studies found a significant difference in the incidence of atopic dermatitis between the 2 feeding groups.…”

“…However, using the criteria of a 2006 Cochrane review, 41 only 14 randomized or quasirandomized (eg, using alternation) trials in term infants compared the use of partially or extensively hydrolyzed formula with the use of human milk or an adapted cow milk formula. [42][43][44][45][46][47][48][49][50][51][52][53][54][55] All of these trials have followed up with at least 80% of study participants. It is important to note that none of these studies reported any adverse effects, including any adverse effect on infant growth.…”