Evidence map›Paper›PMID 34217356›Full record

Trial reportItalian journal of pediatrics2021

Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy.

Rita Nocerino, Carmen Di Scala, Serena Coppola, Veronica Giglio, Laura Carucci, Linda Cosenza, Luana Voto, Anna Maria Iannicelli, Anna Luzzetti, Roberto Berni Canani

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Italian journal of pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03909113 (Tolerability of the New Hypoallergenic Formula in Children With IgE Mediated Cow's Milk Allergy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.1field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03909113 nacompletednot on this map

Tolerability of the New Hypoallergenic Formula in Children With IgE Mediated Cow's Milk Allergy

TypeinterventionalSponsorFederico II UniversityRan2019 to 2020Enrolled29ConditionsAllergy MilkArmsamino acid based formula
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Rita NocerinoDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.ORCID http://orcid.org/0000-0003-4681-546X
Carmen Di ScalaDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Serena CoppolaDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Veronica GiglioDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Laura CarucciDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Linda CosenzaDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Luana VotoDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Anna Maria IannicelliDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Anna LuzzettiDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy.
Roberto Berni CananiDepartment of Translational Medical Science, University of Naples Federico II, Naples, Italy. berni@unina.it.
Ceinge Biotecnologie Avanzate (Italy) · ITUniversity of Naples Federico II · ITFederico II University Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmino acid-based formula (AAF) is a relevant dietary strategy for paediatric patients affected by cow's milk allergy (CMA). The present study was designed to evaluate the hypoallergenicity of a new AAF in children with immunoglobulin (Ig)E-mediated CMA.

methodsAccording to the criteria provided by the American Academy of Pediatrics Subcommittee on Nutrition and Allergic Diseases, we designed a prospective trial in CMA children (aged 1-36 months) aimed to demonstrate the hypoallergenicity of the new AAF in 90% of subjects with 95% confidence during the double-blind, placebo-controlled challenge (DBPCFC). A skin prick test (SPT) with the new AAF was also performed.

resultsTwenty-nine children [all Caucasian, 55.2% male, mean age (±SD) 16.9 ± 5.7 months] were enrolled. The SPT and the DBPCFC with the new AAF were negative in all study subjects.

conclusionsThe study results support the hypoallergenicity of the new AAF. This formula could be considered an additional dietary option for non-breastfed children affected by CMA.

trial registrationThe trial was registered in the ClinicalTrials.gov Protocol Registration System (ID number: NCT03909113 ).

Indexed as

Amino AcidsAnimalsCattleChild, PreschoolDouble-Blind MethodFemaleHumansImmunoglobulin EInfantInfant FormulaMaleMilk HypersensitivityProspective StudiesSkin TestsAmino AcidsImmunoglobulin EDiet therapyFood allergyHypoallergenic formulaInfant formula

Identifiers

PMID34217356
PMCPMC8254988
OpenAlexW3181298275

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.