Feeding Infants Formula With Probiotics or Milk Fat Globule Membrane: A Double-Blind, Randomized Controlled Trial

Abstract

Purpose: To evaluate effects on growth and infection rates of supplementing infant formula with the probiotic Lactobacillus paracasei ssp. paracasei strain F19 (F19) or bovine milk fat globule membrane (MFGM).Methods: In a double-blind, randomized controlled trial, 600 infants were randomized to a formula supplemented with F19 or MFGM, or to standard formula (SF). A breastfed group was recruited as reference (n = 200).The intervention lasted from age 21 ± 7 days until 4 months, and infants were followed until age one year.Results: Both experimental formulas were well tolerated and resulted in high compliance. The few reported adverse events were not likely related to formula, with the highest rates in the SF group, significantly higher than for the F19-supplemented infants (p = 0.046). Weight or length gain did not differ during or after the intervention among the formula-fed groups, with satisfactory growth. During the intervention, overall, the experimental formula groups did not have more episodes of diarrhea, fever, or days with fever than the breastfed infants. However, compared to the breastfed infants, the SF group had more fever episodes (p = 0.021) and days with fever (p = 0.036), but not diarrhea. Compared with the breastfed group, the F19-supplemented infants but not the other two formula groups had more visits/unscheduled hospitalizations (p = 0.015) and borderline more episodes of upper respiratory tract infections (p = 0.048).Conclusions: Both the MFGM- and F19-supplemented formulas were safe and well-tolerated, leading to few adverse effects, similar to the breastfed group and unlike the SF group. During the intervention, the MFGM-supplemented infants did not differ from the breastfed infants in any primary outcome.

Sources, Production, and Clinical Treatments of Milk Fat Globule Membrane for Infant Nutrition and Well-Being

“…In post-hoc analysis, the authors reported a higher (13.9%) rate of eczema in the MFGM-P group compared to the control (3.5%) and MFGM-L (1.4%) groups. The authors commented that their findings should be interpreted with caution and, as noted previously, no increased risk of eczema or rash were demonstrated in two subsequent larger and longer-term feeding studies using the same source (MFGM-10) at equivalent levels [8,9]. A possible interpretation for this discrepancy might be the current lack of a systematic eczema scoring system, which is being developed [171].…”

“…The latest papers that have an in-depth study and large number of subjects are those from Li, X. et al [9] and Li, F. et al [163]. The first study evaluated the effects on growth and infectious outcomes of IF supplemented with either MFGM or a probiotic (L. paracasei ssp.…”

“…The first study evaluated the effects on growth and infectious outcomes of IF supplemented with either MFGM or a probiotic (L. paracasei ssp. paracasei strain F19) [9]. A total of 600 infants were randomized to consume either a standard control formula, formula supplemented with MFGM-10, or formula with probiotic (n = 200 per group) for 4 months.…”

“…The studies summarized here included over 1000 children assigned to MFGM supplementation. Seven of these studies [7,9,155,156,159,161,165] initiated feeding with MFGM-enriched formula at <2 months of age, and five [7,157,159,167] used the same source of MFGM ingredient. Though the majority of studies were designed to follow health and safety outcomes to endpoints of 12 or 18 months, the longest-term follow-ups to date from MFGM feeding in infancy now extend to 6 and 13 years of age [11].…”

“…Among many other important components of HM, an increasing body of evidence shows that the milk fat globule membrane (MFGM) and its constituents support the education and development of the immune system of infants [2][3][4][5][6], which is attributed to both the presence of cholesterol and polar lipids, including phospho-and sphingolipids, and to the abundance of glycosylated and non-glycosylated proteins. Because MFGM can exert diverse positive health effects on immune and GI outcomes, brain development, gut functionality, metabolism, and cognition, as reported in human and animal studies [7][8][9], it seems appropriate to think that the addition of MFGM to infant formula (IF) could bring the product closer to approximating HM composition and function.…”