Trial Outcomes & Findings for Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy (NCT NCT02414243)
NCT ID: NCT02414243
Last Updated: 2020-01-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
14 days
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
New Amino Acid Formula + Control Formula
New Amino-Acid based Infant Formula and then control formula and then open challenge with new amino acid formula
New Amino Acid formula: Ordesa's Amino-Acid based Infant Formula
|
Control Formula + New Amino Acid Formula
Commercially available Amino Acid Formula + New Amino Acid formula + open challenge with newm formula
Commercially available Amino Acid Formula: Commercially available Amino Acid Formula
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
Moved to the Other Group
|
17
|
20
|
|
Overall Study
Entered Open Challenge at Home
|
17
|
20
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
Baseline characteristics by cohort
| Measure |
New Aminoacid Formula + Control
n=19 Participants
Patients that followed the sequence: New aminoacid formula + control formula
|
Control Formula + New Aminoacid Formula
n=20 Participants
Patients that followed the sequence: control formula + new aminoacid formula
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.43 years
STANDARD_DEVIATION 2.78 • n=5 Participants
|
1.78 years
STANDARD_DEVIATION 2.27 • n=7 Participants
|
2.1 years
STANDARD_DEVIATION 2.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Specified
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: 41 subjects were enrolled and randomized to formula sequence. Only 30 subjects completed the Open Challenge with SanorE 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.
Outcome measures
| Measure |
DBPCFC (New Milk SanorE)
n=30 Participants
DBPCFC: Double blind placebo controlled food challenge (New milk)
|
DBPCFC (Control Milk Neocate)
n=30 Participants
DBPCFC: Double blind placebo controlled food challenge (control milk)
|
Open Challenge With SanorE
n=30 Participants
Open challenge with SanorE phase
|
|---|---|---|---|
|
Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
Negative
|
30 Participants
|
30 Participants
|
30 Participants
|
|
Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
Inconclusive
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
DBPCFC (New Milk SanorE)
n=30 Participants
DBPCFC: Double blind placebo controlled food challenge (New milk)
|
DBPCFC (Control Milk Neocate)
DBPCFC: Double blind placebo controlled food challenge (control milk)
|
Open Challenge With SanorE
Open challenge with SanorE phase
|
|---|---|---|---|
|
Cow's Milk Allergy Related Symptoms
V1 Screening
|
1.37 score on a scale
Standard Deviation 1.59
|
—
|
—
|
|
Cow's Milk Allergy Related Symptoms
V4 week 2
|
0.79 score on a scale
Standard Deviation 1.21
|
—
|
—
|
Adverse Events
Global
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Global
n=39 participants at risk
Data from all participants in the study. Data has been presented globally in the final report, no results from different groups. Only occurrence of adverse events.
|
|---|---|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
2.6%
1/39 • Number of events 1 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
Other adverse events
| Measure |
Global
n=39 participants at risk
Data from all participants in the study. Data has been presented globally in the final report, no results from different groups. Only occurrence of adverse events.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
3/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
2/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Gastrointestinal disorders
Pyrexia
|
10.3%
4/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Immune system disorders
Asthma
|
5.1%
2/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.1%
2/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.1%
2/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
4/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
3/39 • From screening visit to week 2
In this study, patients received the two treatments, with the sequence A: New aminoacid formula + control formula; or sequence B: control formula + new aminoacid formula. As all patients received the two treatments, adverse events table does not difference between groups and shows global study population. There were no serious or non-serious adverse events related to the study treatment reported in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place