Evidence map›Paper›PMID 27801789›Full record

Trial reportNutrients2016

Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial.

Maria Elisabetta Baldassarre, Antonio Di Mauro, Paola Mastromarino, Margherita Fanelli, Domenico Martinelli, Flavia Urbano, Daniela Capobianco, Nicola Laforgia

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 4 pooled it
15.8field-weighted citation impact, top 1% 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.

NCT05140928 nacompletednot on this mapstarted 2020, after this paper: background citation

The Effect of Maternal Dadiah (Minangkabau Yogurt) Supplementation During Pregnancy on Child Growth, Gut Microbiota Proportion and the Level of Secretory Immunoglobulin A, in West Sumatra: A Randomised Clinical Trial

TypeinterventionalSponsorAndalas UniversityRan2020 to 2021Enrolled52ConditionsGastrointestinal Microbiome, Immunoglobulin A, Growth, Stunting, NutritionalArmsDadiah Pudding, Pudding without Dadiah
NCT06299358 naunknown statusnot on this mapstarted 2023, after this paper: background citation

The Effect of Foot Massage and Maternal Heart Sound on Colic and Comfort Levels in Infants With Infantile Colic

TypeinterventionalSponsorKaramanoğlu Mehmetbey UniversityRan2023 to 2025Enrolled90ConditionsNurse's Role, Infantile ColicArmsFoot massage, Mother heart sound, Foot massage and maternal heart sound
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 4 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
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  4. Probiotics to prevent infantile colic.The Cochrane database of systematic reviews · 2019
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  16. [Research status and prospects of probiotics in functional gastrointestinal disorders in infants and toddlers].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2024
    Review
  17. Review
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  19. Impact of maternalFrontiers in immunology · 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 2 institutions in 1 country.

Maria Elisabetta BaldassarreDepartment of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. mariaelisabetta.baldassarre@uniba.it.
Antonio Di MauroDepartment of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. antonio.dimauro@uniba.it.
Paola MastromarinoDepartment of Public Health and Infectious Disease, "Sapienza" University of Rome, Rome 00100, Italy. paola.mastromarino@uniroma1.it.
Margherita FanelliDepartment of Interdisciplinary Medicine, "Aldo Moro" University of Bari, Bari 70100, Italy. margherita.fanelli@uniba.it.
Domenico MartinelliDepartment of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. domenico_tine@libero.it.
Flavia UrbanoDepartment of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. flaviaurbano@libero.it.
Daniela CapobiancoDepartment of Public Health and Infectious Disease, "Sapienza" University of Rome, Rome 00100, Italy. daniela.capobianco@uniroma1.it.
Nicola LaforgiaDepartment of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. nicola.laforgia@uniba.it.
University of Bari Aldo Moro · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProbiotic supplementation to women during pregnancy and lactation can modulate breast milk composition, with immune benefits being transferred to their infants.

aimThe aim of the study was to evaluate the effect of high-dose probiotic supplementation to women during late pregnancy and lactation on cytokine profile and secretory IgA (sIgA) in breast milk and thus to study if differences in breast milk composition can affect lactoferrin and sIgA levels in stool samples of newborns. The safety of maternal probiotic administration on neonatal growth pattern and gastrointestinal symptoms were also evaluated.

methodsIn a double-blind, placebo-controlled, randomized trial, 66 women took either the probiotic (

resultsProbiotic maternal consumption had a significant impact on IL6 mean values in colostrum and on IL10 and TGF-β1 mean values in mature breast milk. Fecal sIgA mean values were higher in newborns whose mothers took the probiotic product than in the control group. Probiotic maternal supplementation seems to decrease incidence of infantile colic and regurgitation in infants.

conclusionHigh-dose multi-strain probiotic administration to women during pregnancy influences breast milk cytokines pattern and sIgA production in newborns, and seems to improve gastrointestinal functional symptoms in infants.

Indexed as

LactationMaternal Nutritional Physiological PhenomenaAdultBifidobacteriumColicCytokinesDouble-Blind MethodFemaleGastrointestinal TractHospitals, UniversityHumansIncidenceInfant, NewbornItalyLactobacillusMaleCytokinesfunctional GI diseasesimmunologypediatric gastroenterologyprobiotics/prebiotics

Identifiers

PMID27801789
PMCPMC5133065
OpenAlexW2543440314

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.