Cow Milk Allergy
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTExtensively Hydrolyzed formula
DIETARY_SUPPLEMENTAmino acid formula
Sponsors
United Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: Infants: * with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months, * successfully fed an eviction diet for at least 2 weeks Main Non-inclusion Criteria: Infants: * fed with an extensively hydrolyzed formula with no improvement of the symptoms, * who refused to drink an extensively hydrolyzed formula anytime prior to inclusion, * fed a vegetable based formula * fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations * who had an anaphylactic reaction in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of infants tolerating the formula during a double blind placebo controlled food challenge | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Eczema assessed through SCORAD | 7, 45 and 90 days |
| Weight expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| Regurgitation assessed through Vandenplas score | 7, 45 and 90 days |
| Vomiting (weekly frequency) | 7, 45 and 90 days |
| Abdominal pain (severity on a 4 level scale) | 7, 45 and 90 days |
| Bloating and gas (severity on a 4 level scale) | 7, 45 and 90 days |
| Stool consistency assessed through Bristol Stools Form Scale | 7, 45 and 90 days |
| Sleeping time over 24h | 7, 45 and 90 days |
| Urticaria (presence/absence) | 7, 45 and 90 days |
| Blood in stools (presence/absence) | 7, 45 and 90 days |
| Duration of crying over 24h | 7, 45 and 90 days |
| Respiratory symptoms (severity on a 4 level scale) | 7, 45 and 90 days |
| Height expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| BMI expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| Head circumference expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| Number of patients with treatment emergent Adverse Events | 7, 45 and 90 days |
| Stool frequency over 72h | 7, 45 and 90 days |
Countries
Italy
Outcome results
None listed