title: 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.
authors.affiliation: *Human Nutrition Unit, School of Biological Sciences, University of Auckland, New Zealand †Panchsheel Hospital, Yamuna Vihar ‡Sarvodaya Child Care, Pitampura, New Delhi §M.V. Hospital & Research Centre, Lucknow, India ||Research and Development Centre, Palmerston North ¶University of Otago, Dunedin, New Zealand.
authors.forename: Sally D
authors.initials: SD
authors.lastname: Poppitt
authors.forename: Robin A
authors.initials: RA
authors.lastname: McGregor
authors.forename: Katy R
authors.initials: KR
authors.lastname: Wiessing
authors.forename: Vimal K
authors.initials: VK
authors.lastname: Goyal
authors.forename: Amar J
authors.initials: AJ
authors.lastname: Chitkara
authors.forename: Sarika
authors.initials: S
authors.lastname: Gupta
authors.forename: Kate
authors.initials: K
authors.lastname: Palmano
authors.forename: Barbara
authors.initials: B
authors.lastname: Kuhn-Sherlock
authors.forename: Michelle A
authors.initials: MA
authors.lastname: McConnell
mesh_terms: D000818:Animals; D002417:Cattle; D002675:Child, Preschool; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control* / Q000821:virology; D004311:Double-Blind Method; D005243:Feces / Q000821:virology; D005260:Female; D005732:Gangliosides / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007194:India; D007223:Infant; D008297:Male; D008892:Milk / Q000737:chemistry*; D015995:Prevalence; D011446:Prospective Studies; D012401:Rotavirus; D012400:Rotavirus Infections / Q000150:complications / Q000517:prevention & control* / Q000821:virology; D012621:Seasons; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005732:Gangliosides