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

May 14, 2018 updated by: United Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Umberto I university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extensively hydrolyzed formula
Feeding extensively hydrolyzed formula
Dietary supplement: Extensively Hydrolyzed formula
Placebo Comparator: Amino acid formula
Feeding amino acid formula
Dietary supplement: Amino acid formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Regurgitation assessed through Vandenplas score
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Vomiting (weekly frequency)
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Abdominal pain (severity on a 4 level scale)
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Bloating and gas (severity on a 4 level scale)
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Stool consistency assessed through Bristol Stools Form Scale
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Sleeping time over 24h
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Stool frequency over 72h
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Blood in stools (presence/absence)
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Duration of crying over 24h
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Respiratory symptoms (severity on a 4 level scale)
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Urticaria (presence/absence)
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Eczema assessed through SCORAD
Time Frame: 7, 45 and 90 days
7, 45 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Time Frame: 45 and 90 days
45 and 90 days
Height expressed in z scores according to the WHO Child Growth Standards
Time Frame: 45 and 90 days
45 and 90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Time Frame: 45 and 90 days
45 and 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time Frame: 45 and 90 days
45 and 90 days
Number of patients with treatment emergent Adverse Events
Time Frame: 7, 45 and 90 days
7, 45 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Pharmaceuticals

Investigators

  • Principal Investigator: Salvatore Cucchiara, University Hospital Umberto I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-2014-02-ALYCE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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