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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.

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