Cow's Milk Allergy
Conditions
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).
Detailed description
Not Provided
Interventions
OTHERNew Amino Acid formula
Ordesa's Amino-Acid based Infant Formula
Commercially available Amino Acid Formula
Sponsors
OPBG Clinical & Research Services S.R.L.
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | 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). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cow's Milk Allergy Related Symptoms | 14 days | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Aminoacid Formula + Control Patients that followed the sequence: New aminoacid formula + control formula | 19 |
| Control Formula + New Aminoacid Formula Patients that followed the sequence: control formula + new aminoacid formula | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | New Aminoacid Formula + Control | Control Formula + New Aminoacid Formula | Total |
|---|---|---|---|
| Age, Continuous | 2.43 years STANDARD_DEVIATION 2.78 | 1.78 years STANDARD_DEVIATION 2.27 | 2.1 years STANDARD_DEVIATION 2.52 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 17 Participants | 17 Participants | 34 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Specified | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Italy | 14 participants | 13 participants | 27 participants |
| Region of Enrollment Spain | 5 participants | 7 participants | 12 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 9 / 39 |
| serious Total, serious adverse events | 1 / 39 |
Outcome results
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.
Time frame: 14 days
Population: 41 subjects were enrolled and randomized to formula sequence. Only 30 subjects completed the Open Challenge with SanorE formula.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DBPCFC (New Milk SanorE) | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Inconclusive | 0 Participants |
| DBPCFC (New Milk SanorE) | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Negative | 30 Participants |
| DBPCFC (New Milk SanorE) | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Positive | 0 Participants |
| DBPCFC (Control Milk Neocate) | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Positive | 0 Participants |
| DBPCFC (Control Milk Neocate) | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Inconclusive | 0 Participants |
| DBPCFC (Control Milk Neocate) | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Negative | 30 Participants |
| Open Challenge With SanorE | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Negative | 30 Participants |
| Open Challenge With SanorE | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Inconclusive | 0 Participants |
| Open Challenge With SanorE | Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula | Positive | 0 Participants |
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.
Time frame: 14 days
Population: 41 patients randomized but 30 completed. Results are presented as total score summary . It compares changes between visit 4 and visit 1, and comparison were performed globally. No other result available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DBPCFC (New Milk SanorE) | Cow's Milk Allergy Related Symptoms | V1 Screening | 1.37 score on a scale | Standard Deviation 1.59 |
| DBPCFC (New Milk SanorE) | Cow's Milk Allergy Related Symptoms | V4 week 2 | 0.79 score on a scale | Standard Deviation 1.21 |