Evidence map›Paper›PMID 26465137›Full record

Trial reportAllergy2016

Allergic manifestation 15 years after early intervention with hydrolyzed formulas--the GINI Study.

A von Berg, B Filipiak-Pittroff, H Schulz, U Hoffmann, E Link, M Sußmann, M Schnappinger, I Brüske, M Standl, U Krämer and 6 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Allergy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
8.1field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
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  14. S3 guideline Allergy Prevention.Allergologie select · 2022
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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

16 authors at 6 institutions in 1 country.

A von BergDepartment of Pediatrics, Marien-Hospital Wesel, Research Institute, Wesel, Germany.
B Filipiak-PittroffDepartment of Pediatrics, Marien-Hospital Wesel, Research Institute, Wesel, Germany.
H SchulzInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
U HoffmannInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
E LinkIUF - Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University, Düsseldorf, Germany.
M SußmannInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
M SchnappingerInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
I BrüskeInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
M StandlInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
U KrämerIUF - Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University, Düsseldorf, Germany.
B HoffmannIUF - Leibniz Research Institute for Environmental Medicine at the Heinrich-Heine-University, Düsseldorf, Germany.
J HeinrichInstitute of Epidemiology I, Helmholtz Zentrum Munich, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.
C-P BauerDepartment of Pediatrics, Technical University of Munich, Munich, Germany.
S KoletzkoDr von Hauner Children's Hospital, Ludwig-Maximilians-University, University of Munich Medical Center, Munich, Germany.
D BerdelDepartment of Pediatrics, Marien-Hospital Wesel, Research Institute, Wesel, Germany.
GINIplus study group
Helmholtz Zentrum München · DEMarien Hospital Wesel · DEHeinrich Heine University Düsseldorf · DETechnical University of Munich · DELeibniz Institute of Environmental Medicine · DELudwig-Maximilians-Universität München · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData on the long-term impact of hydrolyzed formulas on allergies are scarce.

objectiveTo assess the association between early intervention with hydrolyzed formulas in high-risk children and allergic outcomes in adolescence.

methodsGINI trial participants (n = 2252) received one of four formulas in the first four months of life as breastmilk substitute if necessary: partial or extensive whey hydrolyzate (pHF-W, eHF-W), extensive casein hydrolyzate (eHF-C) or standard cow's milk formula (CMF) as reference. Associations between these formulas and the cumulative incidence and prevalence of parent-reported physician-diagnosed asthma, allergic rhinitis (AR) and eczema, as well as spirometric indices and sensitization, were examined using generalized linear models.

resultsBetween 11 and 15 years, the prevalence of asthma was reduced in the eHF-C group compared to CMF (odds ratio (OR) 0.49, 95% confidence interval (CI) 0.26-0.89), which is consistent with the spirometric results. The cumulative incidence of AR was lower in eHF-C (risk ratio (RR) 0.77, 95% CI 0.59-0.99]) and the AR prevalence in pHF-W (OR 0.67, 95% CI 0.47-0.95) and eHF-C (OR 0.59, 95% CI 0.41-0.84). The cumulative incidence of eczema was reduced in pHF-W (RR 0.75, 95% CI 0.59-0.96) and eHF-C (RR 0.60, 95% CI 0.46-0.77), as was the eczema prevalence between 11 and 15 years in eHF-C (OR 0.42, 95% CI 0.23-0.79). No significant effects were found in the eHF-W group on any manifestation,nor was there an effect on sensitization with any formula.

conclusionIn high-risk children, early intervention using different hydrolyzed formulas has variable preventative effects on asthma, allergic rhinitis and eczema up to adolescence.

Indexed as

Infant FormulaAdolescentAnimalsCattleChildChild, PreschoolFemaleFollow-Up StudiesHumansHypersensitivityIncidenceInfantInfant, NewbornMaleMilkMilk ProteinsMilk Proteins15-year follow-up from birthallergy preventiondouble-blindhydrolyzed infant formulasnutritional interventionrandomized trial

Identifiers

PMID26465137
PMCPMC4738469
OpenAlexW1903909838

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.