Evidence map›Paper›PMID 33233658›Full record

Trial reportNutrients2020

A Partly Fermented Infant Formula with Postbiotics Including 3'-GL, Specific Oligosaccharides, 2'-FL, and Milk Fat Supports Adequate Growth, Is Safe and Well-Tolerated in Healthy Term Infants: A Double-Blind, Randomised, Controlled, Multi-Country Trial.

Yvan Vandenplas, Virginie de Halleux, Małgorzata Arciszewska, Piotr Lach, Valeriy Pokhylko, Viktoriia Klymenko, Stefanie Schoen, Marieke Abrahamse-Berkeveld, Kelly A Mulder, Rocio Porcel Rubio and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Emerging Nonthermal Technologies for the Production of Postbiotics.Comprehensive reviews in food science and food safety · 2025
    Review
  10. Yogurt in Combination with InactivatedAnimals : an open access journal from MDPI · 2025
    Article
  11. Observational
  12. Review
  13. Respiratory diseases and the gut microbiota: an updated review.Frontiers in cellular and infection microbiology · 2025
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Can Postbiotics Represent a New Strategy for NEC?Advances in experimental medicine and biology · 2024
    Review
  20. 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

11 authors at 7 institutions in 5 countries.

Yvan VandenplasKidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, 1090 Jette, Belgium.ORCID 0000-0002-1862-8651
Virginie de HalleuxCentre Hospitalier Universitaire of Liège (CHU), Centre Hospitalier Régional of Liège (CHR), 4000 Liège, Belgium.
Małgorzata ArciszewskaPoliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k., 15-435 Bialystok, Poland.
Piotr LachCentrum Medyczne Promed, 31-411 Kraków, Poland.
Valeriy PokhylkoUkrainian Medical Stomatological Academy, Poltava Regional Children Clinical Hospital, 36011 Poltava, Ukraine.
Viktoriia KlymenkoKharkiv National Medical University, City Children's Clinical Hospital No. 19, 61051 Kharkiv, Ukraine.
Stefanie SchoenDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.ORCID 0000-0002-4054-1026
Marieke Abrahamse-BerkeveldDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.
Kelly A MulderDanone Nutricia Research, 3584 CT Utrecht, The Netherlands.ORCID 0000-0002-4060-6918
Rocio Porcel RubioHospital Quironsalud, 08023 Barcelona, Spain.
On Behalf Of The Voyage Study Group
Danone (Netherlands) · NLCentre Hospitalier Universitaire de Liège · BECentrum Medyczne iMed24 · PLHospital Quirónsalud Barcelona · ESKharkiv National Medical University · UAUkrainian Medical Stomatological Academy · UAVrije Universiteit Brussel · BE

Funding

Danone Nutricia Research na
6 · The paper itself

Abstract

This study investigated growth, safety, and tolerance in healthy infants consuming a partly fermented infant formula (IF) with postbiotics, 2'-linked fucosyllactose (2'-FL), a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS), and milk fat. This double-blind, controlled trial randomised 215 fully IF-fed infants ≤ 14 days of age to either: Test Group (IF) containing 26% fermented formula with postbiotics derived from Lactofidus fermentation process (including 3'-Galactosyllactose; 3'-GL), 0.8 g/100 mL scGOS/lcFOS (9:1), 0.1 g/100 mL 2'-FL, and milk fat), or Control group (IF with 0.8 g/100 mL scGOS/lcFOS (9:1)) until 17 weeks of age. Fully breastfed infants were included as a reference. Anthropometric measures, gastrointestinal symptoms, and safety were assessed monthly. Equivalence in weight gain (primary outcome) between the Test and Control groups was confirmed (difference in means -0.08 g/day; 90% CI (-1.47;1.31)) with estimated mean weight gain (SE) of 31.00 (0.59) g/day and 31.08 (0.60) g/day, respectively, (PP population,

Indexed as

Fermented FoodsInfant Nutritional Physiological PhenomenaPrebioticsAnimalsBody WeightBreast FeedingDouble-Blind MethodFecesFemaleFermentationFood SafetyGastrointestinal DiseasesHumansInfantInfant FormulaInfant, Newborn2'-fucosyllactose3'-galactosyllactoseOligosaccharidesPrebioticsTrisaccharides2′-linked fucosyllactose (2′-FL)3-galactosyllactose (3′-GL)infant growthpostbioticprebioticsafetytolerance

Identifiers

PMID33233658
PMCPMC7699816
OpenAlexW3102829251

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.