Hypoallergenicity of a thickened hydrolyzed formula in children with cow’s milk allergy

Table 1 Clinical and allergy characteristics of patients in the hypoallergenic population at inclusion (n = 29 patients), n (%)

Characteristics	n (%)
Age, mo	8.03 (7.43)
Male	16 (55.2)
Anthropometric characteristics at birth
WFA z-score, mean ± SD	0.1 (1.0)
LFA z-score, mean ± SD	0.2 (1.3)
HCA z-score, mean ± SD	1.0 (1.0)
Gestational age, mean ± SD, wk	38.5 (2.3)
Preterm	6 (20.7)
Anthropometric characteristics at inclusion
WFA z-score, mean ± SD	-0.3 (1.2)
LFA z-score, mean ± SD	0.0 (1.4)
WFL z-score, mean ± SD	-0.4 (1.0)
BMI-for-age z-score, mean ± SD	-0.4 (1.0)
HCA z-score, mean ± SD	0.7 (1.2)
Feeding history
Breastfeeding in the past	22 (75.9)
Duration of (exclusive and/or partial) breastfeeding, mean ± SD, wk	17.6 (16.2)
Duration of feeding with the formula taken before inclusion, mean ± SD, wk	10.8 (13.1)
Average volume of the formula taken before inclusion, mean ± SD, mL/d	655.2 (199.3)
Solid foods diversification	18 (62.1)
Allergy history
At least one parent or sibling with a medically confirmed allergy	14 (48.3)
Parents’ smoking habits
Past only	5 (17.2)
Current	11 (37.9)
Mother only	4 (13.8)
Father only	6 (20.7)
Both parents	1 (3.4)
Age at onset of first CMA symptoms, mean ± SD, mo	3.6 (4.4)
Time since beginning of the elimination diet, median (min–max; IQR), wk	8.3 (2.0–125.3; 9.7)
Time elapsed between the onset of allergy symptoms and the initiation of the elimination diet, median (min – max; IQR), wk	1.9 (0.1-46.0; 5.7)
Type of first CMA symptoms
Exclusively digestive	10 (34.5)
Exclusively cutaneous	2 (6.9)
Digestive and cutaneous	3 (10.3)
Digestive symptoms and other symptoms such as crying, irritability, abdominal pain, and agitated sleep	5 (17.2)
Digestive symptoms and failure to thrive	6 (20.7)
Digestive, cutaneous and other symptoms such as crying, irritability, and agitated sleep	3 (10.3)
Delay of first CMA symptoms
Immediate	1 (3.4)
Delayed	28 (96.6)
Type of food triggering the first CMA symptoms
Mother’s milk	4 (13.8)
Infant formula	25 (86.2)

SD: Standard deviation; WFA: Weight-for-age; LFA: Length-for-age; WFL: Weight-for-length; BMI: Body mass index; HCA: Head circumference-for-age; CMA: Cow’s milk allergy; IQR: Interquartile range.

Table 2 Characteristics of reactions (immediate and delayed) observed after cow’s milk introduction during the double-blind placebo-controlled food challenge performed before (n = 19) or after study inclusion (n = 10), n (%)

Characteristics of patients with immediate reactions (n = 5)
Types of reactions
Objective gastrointestinal complaints	5 (100.0)
Severe reaction	1 (20.0)
Moderate reaction	1 (20.0)
Mild reaction1	3 (60.0)
Time of reaction after the ingestion of first CMP dose, mean ± SD, min	98.0 (4.5)
Eliciting dose of CMP, mean ± SD, g	2.2 (1.3)
Cumulative dose of CMP, mean ± SD, g	4.7 (2.9)
Characteristics of patients with delayed reactions only (n = 24)
Types of reactions
Digestive and cutaneous symptoms2	2 (8.3)
Upper digestive symptoms (regurgitations and vomiting)2	8 (33.3)
Lower digestive symptoms (changes in stools frequency/consistency and bloody stools)2	9 (37.5)
Lower and upper digestive symptoms2	3 (12.5)
Eczema	1 (4.2)
Irritability/crying3	1 (4.2)
Cumulative dose of CMP, mean ± SD, g	3.9 (1.8)
Time of reaction after hospital discharge
Within 6 h	11 (45.8)
Between 6 and 12 h	5 (20.8)
> 24 h	8 (33.4)

¹These patients also presented delayed digestive reactions, such as diarrhoea or regurgitations, at an average of 3.7 ± 2.1 h after hospital discharge;

²associated with or without general symptoms such as crying, irritability, and changes in behaviour;

³this patient had a positive Skin Prick Test to cow’s milk. CMP: Cow’s milk proteins.

Table 3 mean ± SD anthropometric Z-scores at baseline, Day 45 and Day 90

		LFA z-score	WFL z-score	BMI z-score	HCA z-score
Baseline	n	29	27	27	28
	mean ± SD	0.0 (1.5)	-0.4 (1.0)	-0.4 (1.0)	0.5 (1.2)
D45	n	29	27	27	28
	mean ± SD	0.0 (1.7)	0.0 (1.1)	-0.1 (1.1)	0.5 (1.2)
	P-values1	NS	0.0112	0.0232	NS
D90	n	29	27	27	28
	mean ± SD	0.1 (1.7)	0.3 (1.2)	0.2 (1.2)	0.6 (1.1)
	P-values1	NS	< 0.0013	0.0022	NS

¹P-values vs baseline;

²Student’s t-test;

³Wilcoxon test. D: Day; LFA: Length-for-age; WFL: Weight-for-length; BMI: Body mass index; HCA: Head circumference-for-age; NS: Not significant.