Bovine Complex Milk Lipid Containing Gangliosides for Prevention of Rotavirus Infection and Diarrhoea in Northern Indian Infants

Abstract

Rotavirus (RV) is a leading cause of morbidity and mortality in children younger than 5 years of age, presenting commonly with diarrhoeal symptoms. In a prospective 12-week double-blind randomised controlled trial we assessed acceptability and efficacy of a high-ganglioside complex milk lipid (CML) for prevention of RV infection in 450 infants, ages 8 to 24 months, at 3 sites in northern India. Prevalence of diarrhoea and RV was unseasonably low at baseline (all-cause diarrhoea [ACD], n = 16; RV diarrhoea [RVD], n = 2; RV infection, RV positive [RV+], n = 20) and throughout the trial, with only 110 total episodes of ACD for 12 weeks (CML, n = 62; control, n = 48) of which 10 were RVD (CML, n = 4; control, n = 6). Mean duration that RVD persisted was lower in the CML group (2.3 ± 0.5 days) than that in the control group (3.8 ± 1.3 days, P = 0.03), but only 3 of 450 end of trial stool samples were identified as RV+ (<1%; CML, n = 2; control, n = 1). This hampered the assessment of efficacy of CML, despite the large a priori determined sample size. During the trial similar numbers of infants reported adverse events (AEs: CML 41%, control 46%), with the majority of events classified as mild and not related to the intervention. In conclusion, further clinical trials against a higher background of seasonal prevalence are necessary to assess efficacy of this nutritional intervention to prevent RVD. More important, however, high-ganglioside CML was acceptable for long-term consumption in infants ages 8 to 24 months.

Health benefits of dairy lipids and MFGM in infant formula

“…Indeed in Peruvian infants aged 6 to 11 months, 6 month distribution of complementary food with protein provided as whey protein enriched with the MFGM-enriched protein fraction vs. an equal amount of skim milk protein, reduced the global prevalence of acute diarrhea (3.84 % in the MFGM group vs. 4.37 % in the control group, P < 0.05) (Zavaleta et al, 2011). In contrast, a prospective trial in which 8 to 24 month Indian infants received daily 2 g of complex milk lipids containing 10to 20-fold higher phospholipids than standard commercial IF did not demonstrate a preventing effect on rotavirus diarrhea prevalence (Poppitt et al, 2014). It is noticeable that the incidence of rotavirus infection was unexpectedly low in this trial, hampering the assessment of the supplementation efficacy.…”

Comparative effectiveness and safety of xiyanping with ribavirin for rotavirus enteritis therapy in childhood: A systematic review and meta-analysis

“…Rotavirus (RV) causes acute vomiting, diarrhea, and fever, and is a major cause of enteritis in infants and children younger than 5 years of age, with an estimated 2 million hospitalizations and 450,000 to 700,000 deaths worldwide per year [1]. RV was discovered in 1973 and is the main pathogen in infantile diarrhea in developing countries [2].…”

Towards infant formula biomimetic of human milk structure and digestive behaviour

“…Results are mostly positive and demonstrate benefits in terms of cognition, behaviour, gut health and immunity (Zavaleta et al, 2011;Gurnida et al, 2012;Veereman-Wauters et al, 2012;Billeaud et al, 2014;Poppitt et al, 2014;Timby et al, 2014aTimby et al, , 2014bTimby et al, , 2015. Although the intervention strategy and MFGM concentrates added are still too heterogeneous, these results provide evidence of the beneficial effects of individual components of MFGM.…”