Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula (ALYCE)

United Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cow Milk Allergy

Treatments: Dietary Supplement: Amino acid formula; Dietary Supplement: Extensively Hydrolyzed formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02711163

UP-2014-02-ALYCE

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Extensively hydrolyzed formula

Experimental group

Description:

Feeding extensively hydrolyzed formula

Treatment:

Dietary Supplement: Extensively Hydrolyzed formula

Amino acid formula

Placebo Comparator group

Description:

Feeding amino acid formula

Treatment:

Dietary Supplement: Amino acid formula