A Randomized Placebo-controlled Comparison of 2 Prebiotic/Probiotic Combinations in Preterm Infants: Impact on Weight Gain, Intestinal Microbiota, and Fecal Short-chain Fatty Acids

Department of Pediatrics, University of California, Davis, 95616, USA.
Journal of pediatric gastroenterology and nutrition (Impact Factor: 2.63). 03/2009; 48(2):216-25. DOI: 10.1097/MPG.0b013e31818de195
Source: PubMed


To compare the effect of 2 prebiotic/probiotic products on weight gain, stool microbiota, and stool short-chain fatty acid (SCFA) content of premature infants.
This randomized, blinded, placebo-controlled trial included 90 premature infants treated with either a dietary supplement containing 2 lactobacillus species plus fructooligosaccharides (CUL, Culturelle, ConAgra, Omaha, NE), a supplement containing several species of lactobacilli and bifidobacteria plus fructooligosaccharides (PBP, ProBioPlus DDS, UAS Laboratories, Eden Prairie, MN), or placebo (a dilute preparation of Pregestamil formula) twice daily for 28 days or until discharge if earlier. The primary outcome was weight gain. Secondary outcomes were stool bacterial analysis by culture and 16S rDNA quantitative polymerase chain reaction and stool SCFA content measured by high performance liquid chromatography.
Both prebiotic/probiotic combinations contained more bacterial species than noted on the label. No significant effect on infant growth of either prebiotic/probiotic supplement was observed. By cultures, 64% of infants receiving PBP became colonized with bifidobacteria, compared with 18% of infants receiving CUL and 27% of infants receiving placebo (chi-square, P = 0.064). No differences were noted between groups in colonization rates for lactobacilli, Gram-negative enteric bacteria, or staphylococci. By 16S rDNA polymerase chain reaction analysis, the bifidobacteria content in the stools of the infants receiving PBP was higher than in the infants receiving CUL or placebo (Kruskal-Wallis, P = 0.011). No significant differences in stool SCFA content were detected between groups. No adverse reactions were noted.
Infants receiving PBP were more likely to become colonized with bifidobacteria. No significant differences in weight gain or stool SCFA content were detected.

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Available from: Stephen Bennett, Sep 30, 2015
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    • "Lodinová-Žádníková et al., 2010 Luoto et al., 2010 Maldonado et al., 2010, 2012 Manzoni et al., 2009, 2011 Mihatsch et al., 2010 Mohan et al., 2008. Morisset et al., 2011 Nermes et al., 2011 Niers et al., 2009 Ou et al., 2012 Panigrahi et al., 2008 Rautava et al., 2009 Ritchie et al., 2010 Rojas et al., 2012 Romeo et al., 2011 Rose et al., 2010 Rougé et al., 2009 Rozé et al., 2012 Salmi et al., 2010 Samanta et al., 2008 Sari et al., 2012 Savino et al., 2010 Scalabrin et al., 2009 Soh et al., 2009, 2010 Szajewska et al., 2013 Taipale et al., 2011, 2012 Teran et al., 2009 Underwood et al., 2009 Van der Aa et al., 2010, 2011, 2012 Velaphi et al., 2008 Vlieger et al., 2009 West et al., 2009 Wickens et al., 2012 Yamasaki et al., 2012 Youngster et al., 2011 probiotic strains Bifidobacterium infantis (unspecified), "
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    ABSTRACT: In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.
    Beneficial Microbes 01/2014; 5(1):1-16. DOI:10.3920/BM2013.0046 · 2.61 Impact Factor
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    • "Probiotics improve health in different ways [3,9]. The health benefits conferred by probiotic bacteria are strain specific [3,9]. "
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    ABSTRACT: Background Synbiotics, probiotics or prebiotics are being added to infant formula to promote growth and development in infants. Previous reviews (2007 to 2011) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity. This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics, probiotics or prebiotics. Methods Cochrane methodology was followed using randomized controlled trials (RCTs) which compared term infant formula containing probiotics, prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Where appropriate, meta-analysis was performed; heterogeneity was explored using subgroup and sensitivity analyses. If studies were too diverse a narrative synthesis was provided. Results Three synbiotic studies (N = 475), 10 probiotics studies (N = 933) and 12 prebiotics studies (N = 1563) were included. Synbiotics failed to significantly increase growth in boys and girls. Use of synbiotics increased stool frequency, had no impact on stool consistency, colic, spitting up / regurgitation, crying, restlessness or vomiting. Probiotics in formula also failed to have any significant effect on growth, stool frequency or consistency. Probiotics did not lower the incidence of diarrhoea, colic, spitting up / regurgitation, crying, restlessness or vomiting. Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain. Prebiotics increased stool frequency but had no impact on stool consistency, the incidence of colic, spitting up / regurgitation, crying, restlessness or vomiting. There was no impact of prebiotics on the volume of formula tolerated, infections and gastrointestinal microflora. The quality of evidence was compromised by imprecision, inconsistency of results, use of different study preparations and publication bias. Authors’ conclusions There is not enough evidence to state that supplementation of term infant formula with synbiotics, probiotics or prebiotics does result in improved growth or clinical outcomes in term infants. There is no data available to establish if synbiotics are superior to probiotics or prebiotics.
    Nutrition Journal 10/2012; 11(1):81. DOI:10.1186/1475-2891-11-81 · 2.60 Impact Factor
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    • "The term “synbiotic” is used “when a product contains both probiotics and prebiotics” [43]. In a recently published RCT [44], 90 preterm infants received a dietary supplement containing 2 lactobacillus species plus fructooligosaccharides, a supplement containing several species of Lactobacilli and Bifidobacteria plus fructooligosaccharides, or placebo twice daily for 28 days or until discharge if earlier. The study found that preterm infants who received the supplement containing several species of lactobacilli and bifidobacteria plus fructooligosaccharides were more likely to become colonized with bifidobacteria. "
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    ABSTRACT: Necrotizing enterocolitis (NEC) is the most common serious gastrointestinal disorder affecting very preterm or very low birth weight infants. The risk is inversely proportional to gestational age and weight at birth. Fetal growth restriction and compromise may be additional specific risk factors. Despite extensive research and animal studies etiopathogenesis, preventive strategies and management options remain controversial. The present paper reviews the literature for recent advances and newer insights for changing epidemiological trends, pathogenesis, role of inflammatory cytokines, and various preventive and management strategies.
    09/2012; 2012(4):562594. DOI:10.5402/2012/562594
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