Cow's Milk AllergyRAFNCT02414243

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

A study testing New Amino Acid formula and Commercially available Amino Acid Formula in people with Cow's Milk Allergy, run by Laboratorios Ordesa at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages Up to 12 years
Conditions the study is for: Cow's Milk Allergy
What is being tested?: New Amino Acid formula and Commercially available Amino Acid Formula
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteItaly
Study dates: Apr 2015to 30 Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale Pediatrico Bambino Gesù
Rome

Other trials in Italy

About this study

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

Read the detailed description

Not Provided

Conditions: Cow's Milk Allergy
Being tested: New Amino Acid formula, Commercially available Amino Acid Formula
Medical subject headings: Milk Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New Amino Acid formulaOther
Ordesa's Amino-Acid based Infant Formula
Commercially available Amino Acid FormulaOther
Commercially available Amino Acid Formula

Study groups in NCT02414243
Study group	Role	What they receive
New Amino Acid formula	Experimental	New Amino-Acid based Infant Formula Receives: Other: New Amino Acid formula
Control formula	Active comparator	Commercially available Amino Acid Formula Receives: Other: Commercially available Amino Acid Formula

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 14 days

Secondary outcomes (1)

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.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201530 Dec 2016

First posted10 Apr 2015 (estimated)
Study startApr 2015
Primary completion30 Dec 2016
Study completion30 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02414243
Sponsor's protocol ID: RAF-01-015
Acronym: RAF
Status last verified: Jan 2020
First submitted: 11 Feb 2015
Last updated: 18 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 33006765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy

All Cow's Milk Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02414243
Acronym / sponsor ID: RAF / RAF-01-015
Conditions: Cow's Milk Allergy
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Laboratorios OrdesaIndustry (pharma, biotech, devices)
Collaborators: OPBG Clinical & Research Services S.R.L.
Study start: Apr 2015
Primary completion: 30 Dec 2016 (actual)
Study completion: 30 Dec 2016 (actual)
First posted: 10 Apr 2015 (estimated)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Not Provided

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
New Amino Acid formula	Experimental	Other: New Amino Acid formulaNew Amino-Acid based Infant Formula
Control formula	Active comparator	Other: Commercially available Amino Acid FormulaCommercially available Amino Acid Formula

Who may qualify

Ages: Up to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):
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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
New Amino Acid formulaOrdesa's Amino-Acid based Infant Formula	Other	New Amino Acid formula
Commercially available Amino Acid FormulaCommercially available Amino Acid Formula	Other	Control formula

Primary outcome

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). 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.

1 secondary outcome

Cow's Milk Allergy Related Symptoms
Time frame: 14 days

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Amino Acid Formula + Control Formula	19	13
Control Formula + New Amino Acid Formula	21	17

Primary outcome: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula

Time frame: 14 days. Count of participants. Unit: Participants

Measure	DBPCFC (New Milk SanorE) n = 30	DBPCFC (Control Milk Neocate) n = 30	Open Challenge With SanorE n = 30
Positive	0	0	0
Negative	30	30	30
Inconclusive	0	0	0

Population analysed: 41 subjects were enrolled and randomized to formula sequence. Only 30 subjects completed the Open Challenge with SanorE formula.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From screening visit to week 2. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Global	1 of 39 (2.6%)	9 of 39 (23.1%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33006765Amari 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.

Related trials for Cow's Milk Allergy

Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudia Banzato, MD principal investigator

Azienda Ospedaliera Universitaria Integrata, Verona, Italy

Maria Pedrosa, MD principal investigator

Hospital Universitario La Paz

Elena Alonso, MD principal investigator

Hospital General Universitario Gregorio Marañón, Madrid, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New Amino Acid formula and Commercially available Amino Acid Formula in people with Cow's Milk Allergy, run by Laboratorios Ordesa at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414243, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.