CClinicalTrials.gg
Status unknownNCT02144428Updated May 22, 2014

Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy

An observational study in Cow's Milk Allergy, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to participants aged Up to 36 Months. Per ClinicalTrials.gov, last updated 2014-05-22.

Sponsored by Federico II University · Observational

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
Up to 36 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cow's Milk Allergy
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's planned enrollment of 300 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects with cow's milk allergy diagnosed by family pediatrician operating in Italy

Inclusion criteria

  • subjects with a cow's milk allergy
  • age between 0 to 36 months

Exclusion criteria

Exclusion Criteria:

  • 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,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • lactose intolerance,
  • malignancy,
  • chronic pulmonary diseases,
  • malformations of the gastrointestinal tract.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cow's milk allergy

    Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet

06

What researchers measure

Primary outcomes

  1. Number of subjects with cow's milk allergy tolerant substitutive formulas

    Safety and tolerability of substitutive formulas

    Time frame: At diagnosis and for at least 1 months after the diagnosis

07

Study locations

1 of 1 sites recruiting
  • University of Naples Federico II
    Naples, 80131, Italy
    • Roberto Berni Canani · Contact · 0817462680
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02144428
Lead sponsor
Federico II University
Responsible party
Roberto Berni Canani (MD, PhD, Federico II University) — Principal investigator
First posted
May 22, 2014
Start date
Apr 2011
Primary completion
Nov 2014 (estimated)
Completion
Nov 2014 (estimated)
Last update
May 22, 2014

Study contacts

Roberto Berni Canani, MD, PhD
Contact
0817462680
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion