Cow's Milk AllergyNCT02144428
Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy
An observational study of Cow's Milk Allergy, run by Federico II University at 1 site in Italy.
Trial summary
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Cow's Milk Allergy
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Subjects with cow's milk allergy diagnosed by family pediatrician operating in Italy
Who may be able to join
- subjects with a cow's milk allergy
- age between 0 to 36 months
Who cannot join
- age more than 36 months
- eosinophilic disorders of the gastrointestinal tract,
- food protein induced enterocolitic syndrome,
- concomitant chronic systemic diseases,
- congenital cardiac defects,
- active tuberculosis,
Show all 16Show fewer
- autoimmune diseases,
- immunodeficiency,
- chronic inflammatory bowel diseases,
- celiac disease,
- cystic fibrosis,
- metabolic diseases,
- lactose intolerance,
- malignancy,
- chronic pulmonary diseases,
- malformations of the gastrointestinal tract.
Trial locations and contacts
1 site in 1 country.
Roberto Berni Canani, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
University of Naples Federico II
Naples, 80131
Roberto Berni Canani, 0817462680
About this study
Official title: DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.
- Conditions
- Cow's Milk Allergy
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk allergy | Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with cow's milk allergy tolerant substitutive formulas
Safety and tolerability of substitutive formulas
Measured: At diagnosis and for at least 1 months after the diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startApr 2011
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk AllergyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144428
- Sponsor's protocol ID
- 05/14
- Status last verified
- May 2014
- First submitted
- 14 May 2014
- Last updated
- 22 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY
- ClinicalTrials.gov ID
- NCT02144428
- Acronym / sponsor ID
- 05/14
- Conditions
- Cow's Milk Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cow's milk allergy | – | –Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects with cow's milk allergy diagnosed by family pediatrician operating in Italy
Key inclusion criteria (2 listed)
- subjects with a cow's milk allergy
- age between 0 to 36 months
Key exclusion criteria (16 listed)
- age more than 36 months
- eosinophilic disorders of the gastrointestinal tract,
- food protein induced enterocolitic syndrome,
- concomitant chronic systemic diseases,
- congenital cardiac defects,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects with cow's milk allergy tolerant substitutive formulas
Time frame: At diagnosis and for at least 1 months after the diagnosis
Safety and tolerability of substitutive formulas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Roberto Berni Canani, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Allergy, run by Federico II University 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 2 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 22 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Berni Canani, MD, PhD (0817462680), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with cow's milk allergy tolerant substitutive formulas (time frame: At diagnosis and for at least 1 months after the diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2014.