Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

Cow Milk Allergy Clinical Trial

— ALYCE  

Official title:

Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711163
• Other study ID #: UP-2014-02-ALYCE
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: November 29, 2017

Study information

• Verified date: May 2018
• Source: United Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 29, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Cow Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• Extensively Hydrolyzed formula

• Amino acid formula

Locations

Country	Name	City	State
Italy	Umberto I university hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
United Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of infants tolerating the formula during a double blind placebo controlled food challenge		7 days
Secondary	Regurgitation assessed through Vandenplas score		7, 45 and 90 days
Secondary	Vomiting (weekly frequency)		7, 45 and 90 days
Secondary	Abdominal pain (severity on a 4 level scale)		7, 45 and 90 days
Secondary	Bloating and gas (severity on a 4 level scale)		7, 45 and 90 days
Secondary	Stool consistency assessed through Bristol Stools Form Scale		7, 45 and 90 days
Secondary	Sleeping time over 24h		7, 45 and 90 days
Secondary	Stool frequency over 72h		7, 45 and 90 days
Secondary	Blood in stools (presence/absence)		7, 45 and 90 days
Secondary	Duration of crying over 24h		7, 45 and 90 days
Secondary	Respiratory symptoms (severity on a 4 level scale)		7, 45 and 90 days
Secondary	Urticaria (presence/absence)		7, 45 and 90 days
Secondary	Eczema assessed through SCORAD		7, 45 and 90 days
Secondary	Weight expressed in z scores according to the WHO Child Growth Standards		45 and 90 days
Secondary	Height expressed in z scores according to the WHO Child Growth Standards		45 and 90 days
Secondary	BMI expressed in z scores according to the WHO Child Growth Standards		45 and 90 days
Secondary	Head circumference expressed in z scores according to the WHO Child Growth Standards		45 and 90 days
Secondary	Number of patients with treatment emergent Adverse Events		7, 45 and 90 days