Evidence map›Paper›PMID 31630683›Full record

Trial reportBMC pediatrics2019

Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial.

J Maldonado, M Gil-Campos, J A Maldonado-Lobón, M R Benavides, K Flores-Rojas, R Jaldo, I Jiménez Del Barco, V Bolívar, A D Valero, E Prados and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03204630 (Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk), which is not on this map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT03204630 nacompletednot on this map

Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

TypeinterventionalSponsorBiosearch S.A.Ran2011 to 2015Enrolled236ConditionsInfant NutritionArmsLfer, Bifido, Control
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Nutrients · 2026
    Article
  9. Article
  10. Article
  11. Nutrients · 2023
    Review
  12. Review
  13. Observational
  14. Review
  15. Beneficial Effects ofFrontiers in pediatrics · 2022
    Article
  16. Review
  17. Evaluation of the Effect ofMicroorganisms · 2021
    Review
  18. Review
  19. Review
  20. Review
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

12 authors.

J MaldonadoPediatric Unit, University Hospital Virgen de las Nieves, Granada, Spain.
M Gil-CamposUnit of Metabolism and Pediatric Research (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Cordoba, Spain.
J A Maldonado-LobónBiosearch Life, Research Department, Granada, Spain.
M R BenavidesPediatric Clinic Roquetas, Roquetas de Mar, Almería, Spain.
K Flores-RojasUnit of Metabolism and Pediatric Research (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Cordoba, Spain.
R JaldoAndalusian Health Service, Andalusia, Spain.
I Jiménez Del BarcoClinic "Cristo de la Salud" Albolote, Granada, Spain.
V BolívarAndalusian Health Service, Andalusia, Spain.
A D ValeroBiosearch Life, Research Department, Granada, Spain.
E PradosAndalusian Health Service, Andalusia, Spain.
I PeñalverAndalusian Health Service, Andalusia, Spain.
M OlivaresBiosearch Life, Research Department, Granada, Spain. molivares@biosearchlife.com.ORCID 0000-0002-8596-9923

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe microorganism present in breast milk, added to other factors, determine the colonization of infants. The objective of the present study is to evaluate the safety, tolerance and effects of the consumption of a milk formula during the first year of life that is supplemented with L. fermentum CECT5716 or Bifidobacterium breve CECT7263, two strains originally isolated from breast milk.

methodsA randomized, double blind, controlled, parallel group study including healthy, formula-fed infants was conducted. Two hundred and thirty-six 1-month-old infants were selected and randomly divided into three study groups according to a randomization list. Infants in the control group received a standard powdered infant formula until 12 months of age. Infants in the probiotic groups received the same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263. Main outcome was weigh-gain of infants as safety marker.

resultsOne hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group). The growth of infants in the three groups was consistent with standards. No significant differences were observed in the main outcome, weight-gain (Control group: 5.77 Kg ± 0.95, Lf group: 5.77 Kg ± 1.31, Bb group: 5.58 Kg ± 1.10; p = 0.527). The three milk formulae were well tolerated, and no adverse effects were related to the consumption of any of the formula. Infants receiving B. breve CECT7263 had a 1.7 times lower risk of crying than the control group (OR = 0.569, CI 95% 0.568-0.571; p = 0.001). On the other hand, the incidence of diarrhoea in infants receiving the formula supplemented with L. fermentum CECT5716 was a 44% lower than in infants receiving the control formula (p = 0.014). The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044).

conclusionsThe addition of L. fermentum CECT5716 Lc40 or B. breve CECT7263, two probiotic strains naturally found in breast milk, to infant formulae is safe and induces beneficial effects on the health of infants.

trial registrationThe trial was retrospectively registered in the US Library of Medicine ( www.clinicaltrial.gov ) with the number NCT03204630 . Registered 11 August 2016.

Indexed as

Bifidobacterium breveDietary SupplementsInfant FormulaLimosilactobacillus fermentumChild, PreschoolDouble-Blind MethodFemaleHumansMaleProbioticsTime FactorsTreatment OutcomeColicDiarrhoeaInfant formulaProbioticsSafety

Identifiers

PMID31630683
PMCPMC6802336

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.