Evidence map›Paper›PMID 29494489›Full record

Trial reportNutrients2018

Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial.

Giusy Ranucci, Vittoria Buccigrossi, Eleonora Borgia, Daniela Piacentini, Federica Visentin, Luigi Cantarutti, Paola Baiardi, Mariagrazia Felisi, Maria Immacolata Spagnuolo, Stefania Zanconato and 3 more

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

Trial report in Nutrients, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02116452 (Effects of GOS/PDX Supplemented Formula in Preventing and Modifying the History of Allergy and Acute Infections in a Population of Infants at Risk of Atopy), which is not on this map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 pooled it
11.0field-weighted citation impact, top 1% 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.

NCT02116452 phase3completednot on this map

Effects of GOS/PDX Supplemented Formula in Preventing and Modifying the History of Allergy and Acute Infections in a Population of Infants at Risk of Atopy

TypeinterventionalSponsorFederico II UniversityRan2011Enrolled380ConditionsAtopic DermatitisArmsSupplemented Formula
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 4 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
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  16. The lung-gut crosstalk in respiratory and inflammatory bowel disease.Frontiers in cellular and infection microbiology · 2023
    Review
  17. Review
  18. Review
  19. Observational
  20. S3 guideline Allergy Prevention.Allergologie select · 2022
    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

13 authors at 4 institutions in 1 country.

Giusy RanucciUnit of Pediatrics, Department of Translational Medical Science, University Federico II, Via Pansini 5, 80131 Naples, Italy. giusy.ranucci@opbg.net.
Vittoria BuccigrossiUnit of Pediatrics, Department of Translational Medical Science, University Federico II, Via Pansini 5, 80131 Naples, Italy. buccigro@unina.it.ORCID 0000-0001-7310-4124
Eleonora BorgiaDepartment of Women's and Children's Health, University of Padua, Via Giustiniani 3, 35128 Padua, Italy. eugenio.baraldi@unipd.it.
Daniela PiacentiniDepartment of Women's and Children's Health, University of Padua, Via Giustiniani 3, 35128 Padua, Italy. daniela.piacentini@hotmail.it.
Federica VisentinDepartment of Women's and Children's Health, University of Padua, Via Giustiniani 3, 35128 Padua, Italy. fede82.visentin@gmail.com.
Luigi CantaruttiPedianet Network, 35128 Padua, Italy. l.cantarutti@sosepe.com.
Paola BaiardiIstituti Clinici Scientifici Maugeri SpA Benefit Corporation, Via S. Severino Boezio, 28, 27100 Pavia, Italy. paola.baiardi@icsmaugeri.it.
Mariagrazia FelisiConsorzio per Valutazioni Biologiche e Farmacologiche, Via Luigi Porta, 14, 27100 Pavia, Italy. mfelisi@cvbf.net.ORCID 0000-0002-7315-0857
Maria Immacolata SpagnuoloUnit of Pediatrics, Department of Translational Medical Science, University Federico II, Via Pansini 5, 80131 Naples, Italy. mispagnu@unina.it.
Stefania ZanconatoDepartment of Women's and Children's Health, University of Padua, Via Giustiniani 3, 35128 Padua, Italy. zanconato@pediatria.unipd.it.
Eugenio BaraldiDepartment of Women's and Children's Health, University of Padua, Via Giustiniani 3, 35128 Padua, Italy. eleonborgia@gmail.com.
Carlo GiaquintoDepartment of Women's and Children's Health, University of Padua, Via Giustiniani 3, 35128 Padua, Italy. carlo.giaquinto@unipd.it.
Alfredo GuarinoUnit of Pediatrics, Department of Translational Medical Science, University Federico II, Via Pansini 5, 80131 Naples, Italy. alfguari@unina.it.
University of Padua · ITFederico II University Hospital · ITConsorzio per Valutazioni Biologiche e Farmacologiche · ITIstituti Clinici Scientifici Maugeri · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly nutrition affects the risk of atopy and infections through modifications of intestinal microbiota. The Prebiotics in the Prevention of Atopy (PIPA) study was a 24-month randomised, double-blind, placebo-controlled trial. It aimed to evaluate the effects of a galacto-oligosaccharide/polydextrose (GOS/PDX)-formula (PF) on atopic dermatitis (AD) and common infections in infants who were born to atopic parents and to investigate the relationship among early nutrition, gut microbiota and clinical outcomes.

methodsA total of 201 and 199 infants were randomized to receive a PF and standard formula (SF), respectively; 140 infants remained on exclusive breastfeeding (BF).

resultsThe cumulative incidence of AD and its intensity and duration were not statistically different among the three groups. The number of infants with at least one episode of respiratory infection (RI) and the mean number of episodes until 48 weeks of age were significantly lower in the PF group than in the SF group. The number of patients with recurrent RIs and incidence of wheezing lower RIs until 96 weeks were lower in the PF group than the SF group, but similar to the BF group. Bifidobacteria and Clostridium cluster I colonization increased over time in the PF group but decreased in the SF and BF groups. Bifidobacteria had a protective role in RIs, whereas Clostridium cluster I was associated with atopy protection.

conclusionThe early administration of PF protects against RIs and mediates a species-specific modulation of the intestinal microbiota.

trial registrationclinicaltrial.gov Identifier: NCT02116452.

Indexed as

Dermatitis, AtopicDietary SupplementsDouble-Blind MethodFemaleFood, FormulatedGlucansHumansInfantInfant FormulaInfant, NewbornInfant, PrematureMaleOligosaccharidesPrebioticsGlucansOligosaccharidespolydextrosePrebioticsacute gastroenteritisatopic dermatitisgeneral practicemicrobiomenutritionprebioticsrespiratory infections

Identifiers

PMID29494489
PMCPMC5872704
OpenAlexW2793746167

What OpenQuestion holds

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LicenceCC BY
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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.