Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial.

OBJECTIVES: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. DESIGN: Randomised, double-blind, placebo-controlled trial. SETTING: Community setting in rural India. PARTICIPANTS: LBW infants aged 3-7 days. INTERVENTIONS: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. MAIN OUTCOME MEASURE: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. RESULTS: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). CONCLUSIONS: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants. TRIAL REGISTRATION NUMBER: The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).

Community acquisition of ß-lactamase producing Enterobacteriaceae in neonatal gut.

BACKGROUND: Commensal flora constitutes a reservoir of antibiotic resistance. The increasing variety of ß-lactamases and the emergence of Carbapenem resistant Enterobacteriaceae (CRE) in community, raise concerns regarding efficacy of ß-lactams. It is important to know the exact load of antibiotic resistance in the absence of any antibiotic selection pressure including via food and water.In the present study gut colonization in neonates with no direct antibiotic pressure was used as a model to evaluate ß-lactam resistance in the community. RESULTS: In this prospective study, 75 healthy, vaginally delivered, antibiotic naive, breast fed neonates were studied for gut colonization by Extended spectrum ß-lactamases (ESBL), AmpC ß-lactamases hyperproducing Enterobacteriaceae and CRE on day 0, 21 and 60. Total 267 Enterobacteriaceae were isolated and E.coli was the predominant flora. ESBL, AmpC and coproduction was seen in 20.6%, 19.9% and 11.2% isolates respectively. ESBL carriage increased threefold from day 1 to 60 showing predominance of CTX-M group 15 (82.5%), ampC genes were heterogeneous. Colonization with CRE was rare, only one baby harboured Enterobacter sp positive for kpc-2. The reservoirs for these genes are likely to be mother and the environment. CONCLUSIONS: Data strongly suggests that in absence of any antibiotic pressure there is tremendous load of antibiotic resistance to ß-lactam drugs. Wide spread presence of ESBL and AmpC can drive rapid emergence and dissemination of CRE. This is the first report from India which depicts the smaller picture of true antibiotic pressure present in the Indian community.

Imbalanced dietary profile, anthropometry, and lipids in urban Asian Indian adolescents and young adults.

OBJECTIVE: To analyze the macronutrient, micronutrient, food intake pattern, anthropometry, and lipid profile of urban Asian Indian adolescents and young adults and compare it with the nutrient profile of rural Asian Indian and American adolescents. METHODS: This was a cross-sectional, epidemiologic descriptive study. Body mass index (BMI), percentage body fat, waist and hip circumferences, skinfold thickness, serum lipids, and dietary intake were assessed in 1236 subjects (607 males, 629 females) aged 13-25 years from schools and colleges of a metropolitan city of India. RESULTS: The mean age and BMI of study subjects were 17.6 +/- 2.4 years (range 13-25 years) and 19.8 +/- 3.3 kg/m(2) (range 11.9-35.9 kg/m(2)), respectively. The mean daily percentages of total energy contributed by carbohydrates, total fats, proteins, saturated fatty acids (SFAs), monounsaturated fatty acids (MUFAs), polyunsaturated fatty acids (PUFAs), omega-3 PUFAs, omega-6 PUFAs, and trans-fatty acids for all subjects were 53%, 34%, 11%, 11%, 10%, 9%, 1%, 8%, and 0.3%, respectively. The absolute daily intake of total fat was 84 +/- 29 g/d in males and 72 +/- 21 g/d in females, which was approximately 4 times the recommended dietary allowance for Asian Indians (20-22 g/d). Among food groups, a high intake of milk, milk products, roots, and tubers was observed. In these young individuals, the prevalence of hypercholesterolemia (males > or =169 mg/dl; females > or =181 mg/dl) and overweight (BMI > or =23.1 kg/m(2)) was 14.4% and approximately 16%, respectively. On comparison with rural Asian Indian adolescents, an inappropriately high intake of total fat was observed in our subjects. On the other hand, the percentage of energy intake of SFAs in Asian Indian and American adolescents was at par. CONCLUSIONS: High total fat and SFA intake and a low intake of MUFAs and omega-3 PUFAs showed imbalanced nutrition, which could be responsible for the increasing prevalence of obesity and insulin resistance in urban Asian Indian adolescents and young adults. Nutritional strategies for reducing SFA intake and balancing the omega-3/omega-6 PUFAs ratio should be urgently applied in Asian Indian adolescents and are also presented in this paper.