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CompletedNCT02379598Updated Mar 5, 2015

Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy

An observational study in Cow's Milk Allergy, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 5 Months to 12 Months. Per ClinicalTrials.gov, last updated 2015-03-05.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
5 Months to 12 Months
Sex
All
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Study summary

Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family.

The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction.

There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.

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Conditions studied

  • Cow's Milk Allergy

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03

In context

Milk Hypersensitivity

137 studies on the registry are indexed under Milk Hypersensitivity; 27 are open to participants now.

This study's enrollment of 50 is below the median of 114 across 43 observational studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

Federico II University is the lead sponsor of 365 studies on the registry; 60 are open to participants now.

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

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Who can participate

Ages eligible
5 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children with a sure diagnosis of cow's milk allergy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • subjects with diagnosis of cow's milk allergy

Exclusion criteria

Exclusion Criteria:

  • age \<5 months
  • age >12 months
  • other concomitant chronic diseases
  • malformations
  • other food allergies
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Amino acid based formula

    Dietary Supplement: Aminoacid based formula

  • Whey protein formula

    Dietary Supplement: Hydrolyzed whey formula

Interventions

  • Dietary supplementAminoacid based formula

    Formula based on aminoacid

  • Dietary supplementHydrolyzed whey formula

    Formula based on hydrolyzed whey protein

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What researchers measure

Primary outcomes

  1. change of z-score weight at 12 months

    Time frame: after 12 months of intervention

Secondary outcomes

  1. change of body mass index at 12 months

    Time frame: after 12 months of intervention

07

Study locations

1 site
  • university of naples federico II
    Naples, Naples 80131, Italy
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References and documents

Publications

  • Canani RB, Nocerino R, Frediani T, Lucarelli S, Di Scala C, Varin E, Leone L, Muraro A, Agostoni C. Amino Acid-based Formula in Cow's Milk Allergy: Long-term Effects on Body Growth and Protein Metabolism. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):632-638. doi: 10.1097/MPG.0000000000001337. PubMed 27437928 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02379598
Responsible party
Roberto Berni Canani (MD, PhD, Federico II University) — Principal investigator
First posted
Mar 5, 2015
Start date
May 2012
Primary completion
May 2014
Completion
Dec 2014
Last update
Mar 5, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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