Evidence map›Paper›PMID 27472478›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2016

Partly Fermented Infant Formulae With Specific Oligosaccharides Support Adequate Infant Growth and Are Well-Tolerated.

Frédéric Huet, Marieke Abrahamse-Berkeveld, Sebastian Tims, Umberto Simeoni, Gérard Beley, Christoph Savagner, Yvan Vandenplas, Jonathan O'B Hourihane

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 8% 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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.

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  13. Postbiotics as Metabolites and Their Biotherapeutic Potential.International journal of molecular sciences · 2024
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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

8 authors at 6 institutions in 5 countries.

Frédéric Huet*Hôpital d'Enfants, Dijon, France †Nutricia Research, Utrecht, The Netherlands ‡Center Hospitalier Universitaire Vaudois, Lausanne, Switzerland §Maison de l'enfant Essey- lès- Nancy, Essey- lès- Nancy ||Center Hospitalier Universitaire d'Angers, Angers, France ¶Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium #Department of Paediatrics and Child Health, University College, Cork, Ireland.
Marieke Abrahamse-Berkeveld
Sebastian Tims
Umberto Simeoni
Gérard Beley
Christoph Savagner
Yvan Vandenplas
Jonathan O'B Hourihane
Nutricia Research (Netherlands) · NLCentre Hospitalier Universitaire d'Angers · FRHôpital d'Enfants · FRUniversitair Ziekenhuis Brussel · BEUniversity College Cork · IEUniversity Hospital of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveFermented formulae (FERM) and a specific mixture of 90% short-chain galacto-oligosaccharides and 10% long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1) have a potential beneficial effect on gastrointestinal function and microbiota development in infants. The present study assessed the safety and tolerance of the combination of partly fermented infant milk formulae and scGOS/lcFOS compared with either 1 feature, in healthy term infants.

methodsFour hundred thirty-two infants were enrolled before 28 days of age and followed up to 17 weeks of age and assigned to 1 of the 4 groups: (i) formula with scGOS/lcFOS, (ii) scGOS/lcFOS + 15% FERM, (iii) scGOS/lcFOS + 50% FERM, or (iv) 50% fermented formula (50% FERM). Primary outcome was daily weight gain during intervention (equivalence criterion: difference in daily weight gain ≤3 g/day). Infants' anthropometrics, formula intake, number, and type of (serious) AEs were monitored monthly. Stool samples were collected at baseline and after 17 weeks for analysis of physiological and microbiological parameters.

resultsEquivalence of weight gain per day was demonstrated in both the intention-to-treat and per-protocol population, with a mean weight gain (SD) of 29.7 (6.1), 28.2 (4.8), 28.5 (5.0), and 28.7 (5.9) g/day for the groups i to iv respectively. No differences were observed in other growth parameters, formula intake, and the number or severity of AEs. In all scGOS/lcFOS-containing formulae, a beneficial effect of scGOS/lcFOS was observed, indicated by the lower pH, lower Clostridium difficile levels, and higher secretory immunoglobulin A levels.

conclusionsThe partly fermented infant milk formulae containing the specific mixture scGOS/lcFOS were well-tolerated and resulted in normal growth in healthy infants.

Indexed as

Infant FormulaOligosaccharidesWeight GainClostridioides difficileDouble-Blind MethodFecesFemaleFollow-Up StudiesHumansInfantInfant, NewbornMaleOutcome Assessment, Health CareProspective StudiesfructooligosaccharideOligosaccharides

Identifiers

PMID27472478
PMCPMC5051523
OpenAlexW2513190687

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.