Evidence map›Paper›PMID 32613402›Full record

ArticleMolecular and cellular pediatrics2020

Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial.

Antonia Nomayo, Andreas Schwiertz, Rainer Rossi, Katharina Timme, Janine Foster, Richard Zelenka, Josef Tvrdik, Frank Jochum

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Molecular and cellular pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01603719 (Safety and Efficacy of an Infant Starter Formula With Prebiotics), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 27% 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.

NCT01603719 nacompletednot on this map

Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life

TypeinterventionalSponsorWaldkrankenhaus Protestant Hospital, SpandauRan2011 to 2020Enrolled128ConditionsInfections, Stool Flora, Stool Biochemistry, ConstipationArmsnew infant formula with prebiotics and beta-palmitate
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. 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

8 authors at 3 institutions in 2 countries.

Antonia NomayoDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany. Antonia.nomayo@jsd.de.ORCID http://orcid.org/0000-0003-4570-3933
Andreas SchwiertzInstitute of Microecology, Herborn, Germany.
Rainer RossiDepartment of Pediatrics, Vivantes Klinikum Neukölln, Berlin, Germany.
Katharina TimmeDepartment of Pediatrics, Vivantes Klinikum Neukölln, Berlin, Germany.
Janine FosterDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany.
Richard ZelenkaDMK Baby GmbH, Bremen, Germany.
Josef TvrdikDepartment of Computer Sciences, University of Ostrava, Ostrava, Czech Republic.
Frank JochumDepartment of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany.
Waldkrankenhaus Protestant Hospital · DEVivantes Klinikum · DEUniversity of Ostrava · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe postnatal intestinal colonization of human milk-fed and formula-fed infants differs substantially, as does the susceptibility to infectious diseases during infancy. Specific ingredients in human milk, such as prebiotic human milk oligosaccharides and a specifically structured fat composition with high proportion of beta-palmitic acid (beta-PA) promote the growth of intestinal bifidobacteria, which are associated with favorable effects on infants' health. The present study investigates whether addition of prebiotic galactooligosaccharides (GOS) in combination with higher amounts of beta-PA from cow's milk fat in infant formula positively affects gut microbiota and the incidence of infections in formula-fed infants.

methodsIn a double-blind controlled trial, formula-fed infants were randomly assigned to either receive an experimental formula containing a higher proportion of beta-PA (20-25%) from natural cow's milk fat, and a prebiotic supplement (0.5 g GOS/100 ml), or a standard infant formula with low beta-PA (< 10%), without prebiotics. A breast-fed reference group was also enrolled. After 12 weeks, fecal samples were collected to determine the proportion of fecal bifidobacteria. The number of infections during the first year of life was recorded.

resultsAfter 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001). The incidence of gastrointestinal or other infections during the first year of life did not differ between groups.

conclusionsThe combination of higher amounts of beta-PA plus GOS increased significantly the proportion of fecal bifidobacteria in formula-fed infants, but did not affect the incidence of infections.

trial registrationThe study protocol was registered with Clinical Trials (Protocol Registration and Results System Trial ID: NCT01603719 ) on 05/15/2012 (retrospectively registered).

Indexed as

Beta-palmitic acidBifidobacteriaGalactooligosaccharidesImmunityMicrobiota

Identifiers

PMID32613402
PMCPMC7329970
OpenAlexW3038572894

What OpenQuestion holds

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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.