Clinical trial NCT02711163: Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
Official title: Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cow Milk Allergy
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
timeFrame: 7 days
Secondary outcomes:
measure: Regurgitation assessed through Vandenplas score
timeFrame: 7, 45 and 90 days
measure: Vomiting (weekly frequency)
timeFrame: 7, 45 and 90 days
measure: Abdominal pain (severity on a 4 level scale)
timeFrame: 7, 45 and 90 days
measure: Bloating and gas (severity on a 4 level scale)
timeFrame: 7, 45 and 90 days
measure: Stool consistency assessed through Bristol Stools Form Scale
timeFrame: 7, 45 and 90 days
measure: Sleeping time over 24h
timeFrame: 7, 45 and 90 days
measure: Stool frequency over 72h
timeFrame: 7, 45 and 90 days
measure: Blood in stools (presence/absence)
timeFrame: 7, 45 and 90 days
measure: Duration of crying over 24h
timeFrame: 7, 45 and 90 days
measure: Respiratory symptoms (severity on a 4 level scale)
timeFrame: 7, 45 and 90 days
measure: Urticaria (presence/absence)
timeFrame: 7, 45 and 90 days
measure: Eczema assessed through SCORAD
timeFrame: 7, 45 and 90 days
measure: Weight expressed in z scores according to the WHO Child Growth Standards
timeFrame: 45 and 90 days
measure: Height expressed in z scores according to the WHO Child Growth Standards
timeFrame: 45 and 90 days
measure: BMI expressed in z scores according to the WHO Child Growth Standards
timeFrame: 45 and 90 days
measure: Head circumference expressed in z scores according to the WHO Child Growth Standards
timeFrame: 45 and 90 days
measure: Number of patients with treatment emergent Adverse Events
timeFrame: 7, 45 and 90 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Umberto I university hospital
Study officials:
affiliation: University Hospital Umberto I
name: Salvatore Cucchiara
role: PRINCIPAL_INVESTIGATOR
References: