The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Umberto I university hospital
Roma, Italy
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
Time frame: 7 days
Regurgitation assessed through Vandenplas score
Time frame: 7, 45 and 90 days
Vomiting (weekly frequency)
Time frame: 7, 45 and 90 days
Abdominal pain (severity on a 4 level scale)
Time frame: 7, 45 and 90 days
Bloating and gas (severity on a 4 level scale)
Time frame: 7, 45 and 90 days
Stool consistency assessed through Bristol Stools Form Scale
Time frame: 7, 45 and 90 days
Sleeping time over 24h
Time frame: 7, 45 and 90 days
Stool frequency over 72h
Time frame: 7, 45 and 90 days
Blood in stools (presence/absence)
Time frame: 7, 45 and 90 days
Duration of crying over 24h
Time frame: 7, 45 and 90 days
Respiratory symptoms (severity on a 4 level scale)
Time frame: 7, 45 and 90 days
Urticaria (presence/absence)
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Time frame: 7, 45 and 90 days
Eczema assessed through SCORAD
Time frame: 7, 45 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
Height expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
Number of patients with treatment emergent Adverse Events
Time frame: 7, 45 and 90 days