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

NCT02414243 | Completed Results DMC

• 1 other identifier: RAF-01-015
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cow's Milk Allergy Related Symptoms

  14 days

Study Arms (2)

New Amino Acid formula

EXPERIMENTAL

New Amino-Acid based Infant Formula

Other: New Amino Acid formula

Control formula

ACTIVE COMPARATOR

Commercially available Amino Acid Formula

Other: Commercially available Amino Acid Formula

Interventions

New Amino Acid formula OTHER

Ordesa's Amino-Acid based Infant Formula

New Amino Acid formula

Commercially available Amino Acid Formula OTHER

Commercially available Amino Acid Formula

Control formula

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Ordesa: lead
• OPBG Clinical & Research Services S.R.L.: collaborator

Study Sites (1)

Ospedale Pediatrico Bambino Gesù

Rome, Italy

Location

Related Publications (1)

• 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.

  PMID: 33006765 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Roser De Castellar
• Organization: Laboratorios Ordesa

Roser.DeCastellar@ordesa.es

+34 902105243

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2015
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Locations

IT (1)