Cow's Milk AllergyNCT01634490
Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
An observational study of Cow's Milk Allergy, run by Federico II University.
Trial summary
Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cow's Milk Allergy
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Apr 2012
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis) visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of a diagnostic oral food challenge for cow's milk proteins. Children were in stable clinical condition without signs of CMA already on exclusion diet with an hypoallergenic formula for a period of 7-15 days as presented by the general paediatrician, immediately the symptoms appear and before being attended at the Center for diagnosis of CMA.
Who may be able to join
- Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated
Who cannot join
- Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
About this study
Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.
- Conditions
- Cow's Milk Allergy
- Keywords
- cow's milk allergy, formulas, probiotics
- 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 |
|---|---|---|
| infants receiving extensively hydrolysed casein formula | infants receiving extensively hydrolysed casein formula as substitutive formula | |
| extensively hydrolysed casein formula with Lactobacillus GG | infants receiving extensively hydrolysed casein with LGG as substitutive formula | |
| infants receiving rice hydrolyzed formula | infants receiving rice hydrolyzed formula as substitutive formula | |
| infants receiving soy-based formula | infants receiving soy-based formula as substitutive formula | |
| infants receiving amino-acid based formula | infants receiving amino-acid based formula as substitutive formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy
. Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.
Measured: about 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startOct 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
- 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 (actual)
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
- NCT01634490
- Sponsor's protocol ID
- 013908
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Berni Canani R, Nocerino R, Terrin G, Frediani T, Lucarelli S, Cosenza L, Passariello A, Leone L, Granata V, Di Costanzo M, Pezzella V, Troncone R. Formula selection for management of children with cow's milk allergy influences the rate of acquisition of tolerance: a prospective multicenter study. J Pediatr. 2013 Sep;163(3):771-7.e1. doi: 10.1016/j.jpeds.2013.03.008. Epub 2013 Apr 10.
PubMed 23582142
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT01634490
- Acronym / sponsor ID
- 013908
- Conditions
- Cow's Milk Allergy
- Keywords
- cow's milk allergy, formulas, probiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jul 2012 (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.
Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| infants receiving extensively hydrolysed casein formula | – | –infants receiving extensively hydrolysed casein formula as substitutive formula |
| extensively hydrolysed casein formula with Lactobacillus GG | – | –infants receiving extensively hydrolysed casein with LGG as substitutive formula |
| infants receiving rice hydrolyzed formula | – | –infants receiving rice hydrolyzed formula as substitutive formula |
| infants receiving soy-based formula | – | –infants receiving soy-based formula as substitutive formula |
| infants receiving amino-acid based formula | – | –infants receiving amino-acid based formula as substitutive formula |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis) visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of a diagnostic oral food challenge for cow's milk proteins. Children were in stable clinical condition without signs of CMA already on exclusion diet with an hypoallergenic formula for a period of 7-15 days as presented by the general paediatrician, immediately the symptoms appear and before being attended at the Center for diagnosis of CMA.
Key inclusion criteria (1 listed)
- Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated
Key exclusion criteria (1 listed)
- Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
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
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy
Time frame: about 4 year
. Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- Derived from this study: PubMed 23582142Berni Canani R, Nocerino R, Terrin G, Frediani T, Lucarelli S, Cosenza L, Passariello A, Leone L, Granata V, Di Costanzo M, Pezzella V, Troncone R. Formula selection for management of children with cow's milk allergy influences the rate of acquisition of tolerance: a prospective multicenter study. J Pediatr. 2013 Sep;163(3):771-7.e1. doi: 10.1016/j.jpeds.2013.03.008. Epub 2013 Apr 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Allergy, run by Federico II University.
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 1 inclusion and 1 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 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy (time frame: about 4 year). 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 NCT01634490, 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 6 Jul 2012.