Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy (RAF)

A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy

This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).

Study Overview

• Status: Completed
• Conditions: Cow's Milk Allergy
• Intervention / Treatment: Other: New Amino Acid formula; Other: Commercially available Amino Acid Formula

Detailed Description

Not Provided

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Ospedale Pediatrico Bambino Gesù

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):

  • Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
  • Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum [sIgE>0,35 KUI/L] or skin prick test [SPT ≥ 3 mm]) OR
  • Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
• Aged ≤12 years of age at screening.
• Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
• Written informed consent from one or both parents (depending on the local legislation) or legal representative.

Exclusion Criteria:

• Children who receive breastfeeding at study enrolment.
• Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine [excluding eye drops] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
• Severe anaphylactic reaction [required ≥ 2 doses of epinephrine] to milk or breast milk within the past 2 years;
• Existing illness that could interfere with formula acceptance or identification of allergic reactions.
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Amino Acid formula; New Amino-Acid based Infant Formula	Other: New Amino Acid formula; Ordesa's Amino-Acid based Infant Formula
Active Comparator: Control formula; Commercially available Amino Acid Formula	Other: Commercially available Amino Acid Formula; Commercially available Amino Acid Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula	To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC). Incidence of immediate and/or delayed allergic reactions to the DBPCFC with the study product and/or active comparator and/or during the subsequent OPEN challenge phase of the study.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cow's Milk Allergy Related Symptoms	Cow's Milk Allergy related Symptoms recorded at visit 1 and visit 4 using the Vandenplas symptom-based score (SBS). The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score ≥ 12, the symptoms are likely cow's milk related. This could potentially be CMPA. If final score <12, the symptoms are less likely related to cow's milk. Look for other causes.	14 days

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: OPBG Clinical & Research Services S.R.L.
• Investigators: Principal Investigator: Claudia Banzato, MD, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; Principal Investigator: Maria Pedrosa, MD, Hospital Universitario La Paz; Principal Investigator: Elena Alonso, MD, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Principal Investigator: Montserrat Bosque, MD, Hospital Universitario Parc Taulí Sabadell, Barcelona, Spain; Principal Investigator: Anna Mª Plaza, MD, Hospital Sant Joan de Déu, Barcelona, Spain

Publications and helpful links

General Publications

• Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: RAF-01-015