Evidence map›Paper›PMID 31284424›Full record

Trial reportNutrients2019

Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial.

Alfonso Rodriguez-Herrera, Kelly Mulder, Hetty Bouritius, Rocio Rubio, Antonio Muñoz, Massimo Agosti, Gianluca Lista, Luigi Corvaglia, Thomas Ludwig, Marieke Abrahamse-Berkeveld and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
10.1field-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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
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  5. Hypoallergenicity assessment of an extensively hydrolyzed whey-protein formula in cow's milk allergic infants.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2022
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  8. Observational
  9. Review
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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

11 authors at 8 institutions in 3 countries.

Alfonso Rodriguez-HerreraInstituto Hispalense de Pediatria, 41013 Sevilla, Spain. a.rodriguezherrera@hse.ie.ORCID 0000-0002-1155-280X
Kelly MulderDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.
Hetty BouritiusDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.
Rocio RubioServicio de Pediatría, Hospital Quiron, 08023 Barcelona, Spain.
Antonio MuñozDepartment of Pediatrics, Hospital Clínico Universitario San Cecilio, 18016 Granada, Spain.
Massimo AgostiNeonatologia e Terapia Intensiva Neonatale, Ospedale Filippo Del Ponte di Varese, 21100 Varese, Italy.
Gianluca ListaTerapia Intensiva Neonatale, Ospedale dei Bambini Vittore Buzzi, ASST-FBF-Sacco, 20154 Milano, Italy.
Luigi CorvagliaIntensive Therapy Unit, Hospital S. Orsola Malpighi, 40138 Bologna, Italy.
Thomas LudwigDanone Nutricia Research, Singapore 138671, Singapore.
Marieke Abrahamse-BerkeveldDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.
Juan L Perez-NaveroPediatrics Department, Reina Sofia University Hospital, Maimonides Institute for Biomedical research, CIBERER, 14004 Cordoba, Spain.
Danone (Netherlands) · NLCentre for Biomedical Network Research on Rare Diseases · ESHospital Quirónsalud Barcelona · ESInstituto de Investigación Biosanitaria de Granada · ESInstituto Hispalense de Pediatria · ESIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITOspedale dei Bambini Vittore Buzzi · ITOspedale Filippo Del Ponte Varese · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%;

Indexed as

FermentationPrebioticsAge FactorsBifidobacterium breveChild DevelopmentColicCryingDouble-Blind MethodFecesFemaleFermented FoodsHealthy VolunteersHumansInfantInfant BehaviorInfant FormulafructooligosaccharideOligosaccharidesPrebioticscryingfermented formulagastrointestinal symptomsgrowth adequacyscGOS/lcFOSsleepingstool characteristics

Identifiers

PMID31284424
PMCPMC6683277
OpenAlexW2954920889

What OpenQuestion holds

Textmetadata
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.