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

This study is currently recruiting participants.
Verified July 2016 by Laboratorios Ordesa
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414243
First Posted: April 10, 2015
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
OPBG Clinical & Research Services S.R.L.
Information provided by (Responsible Party):
Laboratorios Ordesa
  Purpose
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).

Condition Intervention Phase
Cow's Milk Allergy Other: New Amino Acid formula Other: Commercially available Amino Acid Formula Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Laboratorios Ordesa:

Primary Outcome Measures:
  • Hypoallergenicity as assessed by reaction to Amino-acid Based Infant Formula [ Time Frame: 14 days ]
    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).


Secondary Outcome Measures:
  • Tolerability to the test formula [ Time Frame: 14 days ]
    Record of adverse events during the study period


Estimated Enrollment: 29
Study Start Date: April 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Not Provided
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414243


Contacts
Contact: Alessandro Fiocchi, Prof alessandro.fiocchi@allegriallergia.net

Locations
Italy
Ospedale Pediatrico Bambino Gesù Recruiting
Rome, Italy
Contact: Alessandro Fiocchi, Doctor         
Sponsors and Collaborators
Laboratorios Ordesa
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
  More Information

Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02414243     History of Changes
Other Study ID Numbers: RAF-01-015
First Submitted: February 11, 2015
First Posted: April 10, 2015
Last Update Posted: July 20, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate