A double-blinded randomized trial on growth and feeding tolerance with Saccharomyces boulardii CNCM I-745 in formula-fed preterm infants

Xu, Liangliang; Wang, Yun; Wang, Yan; Fu, Jianhua; Sun, Mingzhe; Mao, Zhi-Qin; Vandenplas, Yvan

doi:10.1016/j.jped.2015.08.013

Cited by 41 publications

(39 citation statements)

References 22 publications

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“…Since that time, 35 randomized placebo controlled clinical trials with NEC, death and/or sepsis as a reported outcome (the first 33 of these trials have recently been summarized 2 with two additional trials published subsequently 3,4 ) and an additional 10 cohort studies comparing periods of time with universal treatment with probiotics to control periods 2,5 have been published in English language journals. Tables 1 6-12 and 2 1,5,13-17 present the data for the largest of these trials and cohort studies (those with at least 200 infants per arm).…”

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confidence: 99%

Impact of probiotics on necrotizing enterocolitis

Underwood

2017

Seminars in Perinatology

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A large number of randomized placebo-controlled clinical trials and cohort studies have demonstrated a decrease in the incidence of necrotizing enterocolitis with administration of probiotic microbes. These studies have prompted many neonatologists to adopt routine prophylactic administration of probiotics while others await more definitive studies and/or probiotic products with demonstrated purity and stable numbers of live organisms. Cross-contamination and inadequate sample size limit the value of further traditional placebo-controlled randomized controlled trials. Key areas for future research include mechanisms of protection, optimum probiotic species or strains (or combinations thereof) and duration of treatment, interactions between diet and the administered probiotic, and the influence of genetic polymorphisms in the mother and infant on probiotic response. Next generation probiotics selected based on bacterial genetics rather than ease of production and large cluster-randomized clinical trials hold great promise for NEC prevention.

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confidence: 99%

Impact of probiotics on necrotizing enterocolitis

Underwood

2017

Seminars in Perinatology

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“…Finally, 37 studies were eligible for the systematic review [ 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 ]. Details of the included studies are reported in Table 1 ; excluded studies are described in Table 2 .…”

Section: Resultsmentioning

confidence: 99%

Probiotics Prevent Late-Onset Sepsis in Human Milk-Fed, Very Low Birth Weight Preterm Infants: Systematic Review and Meta-Analysis

et al. 2017

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Growing evidence supports the role of probiotics in reducing the risk of necrotizing enterocolitis, time to achieve full enteral feeding, and late-onset sepsis (LOS) in preterm infants. As reported for several neonatal clinical outcomes, recent data have suggested that nutrition might affect probiotics’ efficacy. Nevertheless, the currently available literature does not explore the relationship between LOS prevention and type of feeding in preterm infants receiving probiotics. Thus, the aim of this systematic review and meta-analysis was to evaluate the effect of probiotics for LOS prevention in preterm infants according to type of feeding (exclusive human milk (HM) vs. exclusive formula or mixed feeding). Randomized-controlled trials involving preterm infants receiving probiotics and reporting on LOS were included in the systematic review. Only trials reporting on outcome according to feeding type were included in the meta-analysis. Fixed-effects models were used and random-effects models were used when significant heterogeneity was found. The results were expressed as risk ratio (RR) with 95% confidence interval (CI). Twenty-five studies were included in the meta-analysis. Overall, probiotic supplementation resulted in a significantly lower incidence of LOS (RR 0.79 (95% CI 0.71–0.88), p < 0.0001). According to feeding type, the beneficial effect of probiotics was confirmed only in exclusively HM-fed preterm infants (RR 0.75 (95% CI 0.65–0.86), p < 0.0001). Among HM-fed infants, only probiotic mixtures, and not single-strain products, were effective in reducing LOS incidence (RR 0.68 (95% CI 0.57–0.80) p < 0.00001). The results of the present meta-analysis show that probiotics reduce LOS incidence in exclusively HM-fed preterm infants. Further efforts are required to clarify the relationship between probiotics supplementation, HM, and feeding practices in preterm infants.

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“…We included the data for these groups separately in the meta-analysis. Studies were conducted in 13 different countries with 9 studies conducted in India [18,46,49,54,57,59,64,66,68], 6 studies in Turkey [44,45,48,56,61,62], 3 studies each in Iran [38,43,63] and China [42,51,67], 2 each in South Africa [41,55], and Mexico [47,50] and one each in Brazil [39], Bangladesh [40], Colombia [58], Indonesia [53], Nepal [68], Pakistan [52] and Thailand [60]. All the studies were conducted in the hospital setting except three studies where participants were followed in the community settings [41,57,68].…”

Section: Probiotic Supplementation During the Neonatal Periodmentioning

confidence: 99%

“…Effect of neonatal probiotic supplementation on incidence of Necrotizing Enterocolitis.Neonatal SepsisData were available from twenty-one studies that included 9105 (probiotics 4606, Control 4499)[18,39,[42][43][44][45][46][48][49][50]53,54,57,[59][60][61][62][63][65][66][67]. The pooled results showed a reduction of 22% in the intervention group compared to control (RR 0.78, 95% CI 0.70) (Supplementary…”

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confidence: 99%

Effect of Synthetic Vitamin A and Probiotics Supplementation for Prevention of Morbidity and Mortality during the Neonatal Period. A Systematic Review and Meta-Analysis of Studies from Low- and Middle-Income Countries

et al. 2020

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Background: Suboptimal nutritional status of a newborn is a risk factor for short-and long-term morbidity and mortality. The objectives of this review were to assess the efficacy and effectiveness of neonatal synthetic vitamin A supplementation, dextrose gel and probiotic supplementation for prevention of morbidity and mortality during infancy in low and middle-income countries. Methods: We included randomized trials. Primary outcome was all-cause mortality. We conducted electronic searches on multiple databases. Data were meta-analyzed to obtain relative risk (RR) and 95% confidence interval (CI). Studies for vitamin A and Probiotics were analyzed separately. No studies were found for dextrose gel supplementation during neonatal period. The overall rating of evidence was determined by Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Sixteen studies assessed the effect of vitamin A supplementation during the neonatal period. Based on pooled data from community-based studies only, there was no significant effect of vitamin A on all-cause mortality at age 1 month (RR 0.99, 95% CI 0.90, 1.08), 6 months (RR 0.98; 95% CI 0.89-1.08) and 12 months (RR 1.04, 95% CI 0.94, 1.14) but increased risk of bulging fontanelle (RR 1.53, 95% CI 1.12, 2.09). The overall quality of evidence was high for the above outcomes. Thirty-three studies assessed the effect of probiotic supplementation during the neonatal period and were mostly conducted in the hospital setting. Probiotics reduced the risk of all-cause mortality (RR 0.80, 95% CI 0.66, 0.96), necrotizing enterocolitis (RR 0.46, 95% CI 0.35, 0.59) and neonatal sepsis (RR 0.78, 95% CI 0.70, 0.86). The grade ratings for the above three outcomes were high. Conclusions: Vitamin A supplementation during the neonatal period does not reduce all-cause neonatal or infant mortality in low and middle-income countries in the community setting. Probiotic supplementation during the neonatal period seems to reduce all-cause mortality, NEC, and sepsis in babies born low birth weight and/or preterm in the hospital setting.

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A double-blinded randomized trial on growth and feeding tolerance with Saccharomyces boulardii CNCM I-745 in formula-fed preterm infants

Abstract: Prophylactic supplementation of S. boulardii at a dose of 50mg/kg twice a day improved weight gain, improved feeding tolerance, and had no adverse effects in preterm infants >30 weeks old.

Cited by 41 publications

References 22 publications

Impact of probiotics on necrotizing enterocolitis

Impact of probiotics on necrotizing enterocolitis

Probiotics Prevent Late-Onset Sepsis in Human Milk-Fed, Very Low Birth Weight Preterm Infants: Systematic Review and Meta-Analysis

Effect of Synthetic Vitamin A and Probiotics Supplementation for Prevention of Morbidity and Mortality during the Neonatal Period. A Systematic Review and Meta-Analysis of Studies from Low- and Middle-Income Countries

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