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

Cow's Milk Allergy Clinical Trial

— RAF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414243
• Other study ID #: RAF-01-015
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: January 2020
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Not Provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• New Amino Acid formula
Ordesa's Amino-Acid based Infant Formula
• Commercially available Amino Acid Formula
Commercially available Amino Acid Formula

Locations

Country	Name	City	State
Italy	Ospedale Pediatrico Bambino Gesù	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	OPBG Clinical & Research Services S.R.L.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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