Trial reportPloS one2021
Serum cytokine patterns are modulated in infants fed formula with probiotics or milk fat globule membranes: A randomized controlled trial.
Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Probiotic supplementation is associated with higher faecal secretory IgA (sIgA) in healthy full-term infants: a systematic review and meta-analysis.Pediatric research · 2026Pooled it
- Immunological effects of alpha-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.Journal of pediatric gastroenterology and nutrition · 2025Trial
- NorthPop: a prospective population-based birth cohort study.BMC public health · 2025Article
- Functional Significance of Probiotic Bacterial Interactions with Milk Fat Globules in a Human Host.Microorganisms · 2025Review
- Article
- Effect of Pre-, Pro-, and Synbiotics on Biomarkers of Systemic Inflammation in Children: A Scoping Review.Nutrients · 2024Article
- Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial.Frontiers in nutrition · 2024Article
- Pre-, pro-, syn-, and Postbiotics in Infant Formulas: What Are the Immune Benefits for Infants?Nutrients · 2023Review
- Review
- The Immunological Role of Milk Fat Globule Membrane.Nutrients · 2022Review
- Brain-immune-gut benefits with early life supplementation of milk fat globule membrane.JGH open : an open access journal of gastroenterology and hepatology · 2022Review
- Metabolic Phenotype and Microbiome of Infants Fed Formula ContainingFrontiers in pediatrics · 2022Article
- Infant Formula Based on Milk Fat Affects Immune Development in Both Normal Birthweight and Fetal Growth Restricted Neonatal Piglets.Nutrients · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProteins and lipids of milk fat globule membrane (MFGM) and probiotics are immunomodulatory. We hypothesized that Lactobacillus paracasei ssp. paracasei strain F19 (F19) would augment vaccine antibody and T helper 1 type immune responses whereas MFGM would produce an immune response closer to that of breastfed (BF) infants.
objectiveTo compare the effects of supplementing formula with F19 or bovine MFGM on serum cytokine and vaccine responses of formula-fed (FF) and BF infants.
designFF infants were randomized to formula with F19 (n = 195) or MFGM (n = 192), or standard formula (SF) (n = 194) from age 21±7 days until 4 months. A BF group served as reference (n = 208). We analyzed seven cytokines (n = 398) in serum at age 4 months using magnetic bead-based multiplex technology. Using ELISA, we analyzed anti-diphtheria IgG (n = 258) and anti-poliovirus IgG (n = 309) concentrations in serum before and after the second and third immunization, respectively.
resultsCompared with SF, the F19 group had greater IL-2 and lower IFN-γ concentrations (p<0.05, average effect size 0.14 and 0.39). Compared with BF, the F19 group had greater IL-2, IL-4 and IL-17A concentrations (p<0.05, average effect size 0.42, 0.34 and 0.26, respectively). The MFGM group had lower IL-2 and IL-17A concentrations compared with SF (p<0.05, average effect size 0.34 and 0.31). Cytokine concentrations were comparable among the MFGM and BF groups. Vaccine responses were comparable among the formula groups.
conclusionsContrary to previous studies F19 increased IL-2 and lowered IFN-γ production, suggesting that the response to probiotics differs across populations. The cytokine profile of the MFGM group approached that of BF infants, and may be associated with the previous finding that infectious outcomes for the MFGM group in this cohort were closer to those of BF infants, as opposed to the SF group. These immunomodulatory effects support future clinical evaluation of infant formula with F19 or MFGM.
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