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

Primary Purpose

Cow Milk Allergy

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Extensively Hydrolyzed formula
Amino acid formula
Sponsored by
United Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow Milk Allergy

Eligibility Criteria

1 Month - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Umberto I university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Extensively hydrolyzed formula

Amino acid formula

Arm Description

Feeding extensively hydrolyzed formula

Feeding amino acid formula

Outcomes

Primary Outcome Measures

Percentage of infants tolerating the formula during a double blind placebo controlled food challenge

Secondary Outcome Measures

Regurgitation assessed through Vandenplas score
Vomiting (weekly frequency)
Abdominal pain (severity on a 4 level scale)
Bloating and gas (severity on a 4 level scale)
Stool consistency assessed through Bristol Stools Form Scale
Sleeping time over 24h
Stool frequency over 72h
Blood in stools (presence/absence)
Duration of crying over 24h
Respiratory symptoms (severity on a 4 level scale)
Urticaria (presence/absence)
Eczema assessed through SCORAD
Weight expressed in z scores according to the WHO Child Growth Standards
Height expressed in z scores according to the WHO Child Growth Standards
BMI expressed in z scores according to the WHO Child Growth Standards
Head circumference expressed in z scores according to the WHO Child Growth Standards
Number of patients with treatment emergent Adverse Events

Full Information

First Posted
March 8, 2016
Last Updated
May 14, 2018
Sponsor
United Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02711163
Brief Title
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
Acronym
ALYCE
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extensively hydrolyzed formula
Arm Type
Experimental
Arm Description
Feeding extensively hydrolyzed formula
Arm Title
Amino acid formula
Arm Type
Placebo Comparator
Arm Description
Feeding amino acid formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Extensively Hydrolyzed formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino acid formula
Primary Outcome Measure Information:
Title
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Regurgitation assessed through Vandenplas score
Time Frame
7, 45 and 90 days
Title
Vomiting (weekly frequency)
Time Frame
7, 45 and 90 days
Title
Abdominal pain (severity on a 4 level scale)
Time Frame
7, 45 and 90 days
Title
Bloating and gas (severity on a 4 level scale)
Time Frame
7, 45 and 90 days
Title
Stool consistency assessed through Bristol Stools Form Scale
Time Frame
7, 45 and 90 days
Title
Sleeping time over 24h
Time Frame
7, 45 and 90 days
Title
Stool frequency over 72h
Time Frame
7, 45 and 90 days
Title
Blood in stools (presence/absence)
Time Frame
7, 45 and 90 days
Title
Duration of crying over 24h
Time Frame
7, 45 and 90 days
Title
Respiratory symptoms (severity on a 4 level scale)
Time Frame
7, 45 and 90 days
Title
Urticaria (presence/absence)
Time Frame
7, 45 and 90 days
Title
Eczema assessed through SCORAD
Time Frame
7, 45 and 90 days
Title
Weight expressed in z scores according to the WHO Child Growth Standards
Time Frame
45 and 90 days
Title
Height expressed in z scores according to the WHO Child Growth Standards
Time Frame
45 and 90 days
Title
BMI expressed in z scores according to the WHO Child Growth Standards
Time Frame
45 and 90 days
Title
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time Frame
45 and 90 days
Title
Number of patients with treatment emergent Adverse Events
Time Frame
7, 45 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Cucchiara
Organizational Affiliation
University Hospital Umberto I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umberto I university hospital
City
Roma
Country
Italy

12. IPD Sharing Statement

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Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

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