Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
Phase 3
Completed
- Conditions
- Cow Milk Allergy
- Registration Number
- NCT02711163
- Lead Sponsor
- United Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Percentage of infants tolerating the formula during a double blind placebo controlled food challenge 7 days
- Secondary Outcome Measures
Name Time Method Regurgitation assessed through Vandenplas score 7, 45 and 90 days Abdominal pain (severity on a 4 level scale) 7, 45 and 90 days Weight expressed in z scores according to the WHO Child Growth Standards 45 and 90 days Stool consistency assessed through Bristol Stools Form Scale 7, 45 and 90 days Urticaria (presence/absence) 7, 45 and 90 days Eczema assessed through SCORAD 7, 45 and 90 days Vomiting (weekly frequency) 7, 45 and 90 days Bloating and gas (severity on a 4 level scale) 7, 45 and 90 days Sleeping time over 24h 7, 45 and 90 days Stool frequency over 72h 7, 45 and 90 days Blood in stools (presence/absence) 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 Duration of crying over 24h 7, 45 and 90 days
Trial Locations
- Locations (1)
Umberto I university hospital
🇮🇹Roma, Italy
Umberto I university hospital🇮🇹Roma, Italy