Evidence map›Paper›PMID 24671237›Full record

Trial reportEuropean journal of nutrition2015

Prebiotic effect during the first year of life in healthy infants fed formula containing GOS as the only prebiotic: a multicentre, randomised, double-blind and placebo-controlled trial.

Carlos Sierra, María-José Bernal, Javier Blasco, Rosario Martínez, Jaime Dalmau, Inmaculada Ortuño, Beatriz Espín, María-Isabel Vasallo, David Gil, María-Luisa Vidal and 5 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of nutrition, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 8 pooled it
8.4field-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

66 citing papers in PubMed, 8 syntheses or guidelines pooled it, 155 citations in OpenAlex.

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6 more citing papers are in PubMed but not listed here.

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

15 authors at 10 institutions in 2 countries.

Carlos SierraHospital Materno-Infantil, Avda. Arroyo de los Ángeles s/n, 29011, Málaga, Spain.
María-José Bernal
Javier Blasco
Rosario Martínez
Jaime Dalmau
Inmaculada Ortuño
Beatriz Espín
María-Isabel Vasallo
David Gil
María-Luisa Vidal
Dámaso Infante
Rosaura Leis
José Maldonado
José-Manuel Moreno
Enriqueta Román
Hero España (Spain) · ESHospital Materno-Infantil · ESComplejo Hospitalario Universitario de Santiago · ESHebron University · PSHospital Universitario 12 De Octubre · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario Virgen de la Arrixaca · ESHospital Universitario Virgen de las Nieves · ESHospital Universitario Virgen del Rocío · ESLeitat Technological Center · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCurrently, there is no consensus concerning the possible beneficial colonic and systemic effects of prebiotic-containing infant formula. This study assesses whether the feeding of a galactooligosaccharides (GOS)-containing infant formula (0.44 g/dl of GOS) and the subsequent feeding of a GOS-containing follow-on formula (0.50 g/dl of GOS) have a prebiotic effect on intestinal microbiota that helps to decrease infections and allergy manifestations in healthy infants during the first year of life.

methodsA multicentre, randomised, double-blind and placebo-controlled trial was carried out on 365 healthy term infants enrolled before 8 weeks of age and randomly assigned to a formula with or without GOS, until 12 months of age. The incidence of infections and allergy manifestations, the antibiotics prescribed and faecal characteristics were recorded up to 12 months of age, while faecal samples were collected up to 4 months for the measurement of secretory immunoglobulin A, short-chain fatty acids and microbiota.

resultsA prebiotic effect on the faecal analysis was observed at 4 months of life. The GOS group showed a lower faecal pH (P = 0.019), a lower decreasing trend in secretory immunoglobulin A (P = 0.078), lower butyric acid concentration (P = 0.040) and an increase in Bifidobacterium counts (P = 0.010). Changes in faecal characteristics involved greater frequency (P < 0.001) and softer consistency (P < 0.05). The incidence of infections or allergic manifestations during the first year of life was similar in both groups, with no statistical differences (P > 0.05).

conclusionsThe feeding of GOS-containing infant formula produced a definite prebiotic effect consisting of changes in faecal composition and microbiota, and in faecal consistency and the frequency of defaecation. No changes in the incidence of infection or allergic manifestation during the first year of life were observed.

Indexed as

Immunity, InnateInfant FormulaPrebioticsAnti-Allergic AgentsBifidobacteriumCohort StudiesConstipationDouble-Blind MethodFatty Acids, VolatileFecesHumansHypersensitivityImmunoglobulin A, SecretoryImmunologic FactorsIncidenceInfant4'-galactooligosaccharideAnti-Allergic AgentsFatty Acids, VolatileImmunoglobulin A, SecretoryImmunologic FactorsOligosaccharidesPrebioticsTrisaccharides

Identifiers

PMID24671237
PMCPMC4303717
OpenAlexW2016178247

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.