Bifidobacterium Septicemia Associated with Postoperative Probiotic Therapy in a Neonate with Omphalocele

Ohishi, Akira; Takahashi, Satoshi; Ito, Yushi; Ohishi, Yoshihisa; Tsukamoto, Keiko; Nanba, Yūsuke; Ito, Naoki; Kakiuchi, Soji; Saitoh, Akihiko; Morotomi, Masami; Nakamura, Tomoo

doi:10.1016/j.jpeds.2009.11.041

Cited by 143 publications

(94 citation statements)

References 10 publications

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“…This is similar to other probiotic trials, although isolated cases of probiotic sepsis in NICU infants have been reported. 38,39 The strengths of the ProPrems trial are the blinded randomized design, the participant target population of very preterm infants derived from neonatal units with high breast milk feeding rates, and the largest sample size of RCTs to date. The precise and reproducible definition of late-onset sepsis is also a strength and underpins our finding that there is no significant effect of probiotic administration with this combination on definite late-onset sepsis in very preterm infants.…”

Section: Discussionmentioning

confidence: 99%

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

Tobin²,

et al. 2013

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BACKGROUND AND OBJECTIVE: Late-onset sepsis frequently complicates prematurity, contributing to morbidity and mortality. Probiotics may reduce mortality and necrotizing enterocolitis (NEC) in preterm infants, with unclear effect on late-onset sepsis. This study aimed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis. METHODS: A prospective multicenter, double-blinded, placebo-controlled, randomized trial compared daily administration of a probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis, containing 1 × 109 total organisms) with placebo (maltodextrin) in infants born before 32 completed weeks’ gestation weighing <1500 g. The primary outcome was at least 1 episode of definite late-onset sepsis. RESULTS: Between October 2007 and November 2011, 1099 very preterm infants from Australia and New Zealand were randomized. Rates of definite late-onset sepsis (16.2%), NEC of Bell stage 2 or more (4.4%), and mortality (5.1%) were low in controls, with high breast milk feeding rates (96.9%). No significant difference in definite late-onset sepsis or all-cause mortality was found, but this probiotic combination reduced NEC of Bell stage 2 or more (2.0% versus 4.4%; relative risk 0.46, 95% confidence interval 0.23 to 0.93, P = .03; number needed to treat 43, 95% confidence interval 23 to 333). CONCLUSIONS: The probiotics B infantis, S thermophilus, and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants, but not definite late-onset sepsis or mortality. Treatment with this combination of probiotics appears to be safe.

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Section: Discussionmentioning

confidence: 99%

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

Tobin²,

et al. 2013

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“…In 2010, what we believe to be the first case of a Bifidobacterium septicaemia was reported. 52 This involved a positive blood culture for B. breve strain BBG-001 (the strain used for the PiPS trial) in a full-term baby recovering after surgery for exomphalos. The baby is described as having a mild illness that was treated with standard empirical antibiotic treatment involving ampicillin/sulbactam and amikacin; the child made an uneventful recovery.…”

Section: Safetymentioning

confidence: 99%

A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infantS (PiPS) trial

Costeloe

Bowler

Brocklehurst

et al. 2016

Health Technol Assess

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BackgroundNecrotising enterocolitis (NEC) and late-onset sepsis remain important causes of death and morbidity in preterm babies. Probiotic administration might strengthen intestinal barrier function and provide protection; this is supported by published meta-analyses, but there is a lack of large well-designed trials.ObjectiveTo test the use of the probioticBifidobacterium brevestrain BBG-001 to prevent NEC, late-onset sepsis and death in preterm babies while monitoring probiotic colonisation of participants.DesignDouble-blind, randomised, placebo-controlled trial.SettingRecruitment was carried out in 24 hospitals, and the randomisation programme used a minimisation algorithm. Parents, clinicians and outcome assessors were blinded to the allocation.ParticipantsBabies born between 23 and 30 weeks’ gestation and randomised within 48 hours of birth. Exclusions included life-threatening or any gastrointestinal malformation detected within 48 hours of birth and no realistic chance of survival.InterventionsActive intervention: 1 ml ofB. breveBBG-001 in one-eighth-strength infant formula Neocate®(Nutricia Ltd, Trowbridge, UK), (6.7 × 107to 6.7 × 109colony-forming units) per dose administered enterally. Placebo: 1 ml of one-eighth-strength infant formula Neocate. Started as soon as practicable and continued daily until 36 weeks’ postmenstrual age.Main outcome measuresPrimary outcomes were an episode of bloodstream infection, with any organism other than a skin commensal, in any baby between 72 hours and 46 weeks’ postmenstrual age; an episode of NEC Bell stage ≥ 2 in any baby; and death before discharge from hospital. Secondary outcomes included stool colonisation withB. breve.ResultsIn total, 654 babies were allocated to receive probiotic and 661 to receive placebo over 37 months from July 2010. Five babies were withdrawn; 650 babies from the probiotic group and 660 from the placebo group were included in the primary analysis. Baseline characteristics were well balanced. There was no evidence of benefit for the primary outcomes {sepsis: 11.2% vs. 11.7% [adjusted relative risk (RR) 0.97, 95% confidence interval (CI) 0.73 to 1.29]; NEC Bell stage ≥ 2: 9.4% vs. 10.0% [adjusted RR 0.93, 95% CI 0.68 to 1.27]; and death: 8.3% vs. 8.5% [adjusted RR 0.93, 95% CI 0.67 to 1.30]}.B. brevecolonisation status was available for 1186 (94%) survivors at 2 weeks’ postnatal age, of whom 724 (61%) were positive: 85% of the probiotic group and 37% of the placebo group. There were no differences for subgroup analyses by minimisation criteria and by stool colonisation withB. breveat 2 weeks. No harms associated with the interventions were reported.LimitationsCross-colonisation of the placebo arm could have reduced statistical power and confounded results; analyses suggest that this did not happen.ConclusionsThis is the largest trial to date of a probiotic intervention. It shows no evidence of benefit and does not support routine use of probiotics for preterm infants.Future work recommendationsThe increasing understanding of the pathogenesis of NEC and sepsis will inform the choice of probiotics for testing and better define the target population. Future Phase III trials should incorporate monitoring of the quality and viability of the intervention and colonisation rates of participants; cluster design should be considered.Trial registrationCurrent Controlled Trials ISRCTN05511098 and EudraCT 2006-003445-17.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 66. See the NIHR Journals Library website for further project information.

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“…The episodes of sepsis due to Bifidobacterium described in the medical literature are few, they are isolated cases and in the pediatric patients they preferentially affect preterm infants with very low birth weight (generally less than 1,500 grams), with infections of the periumbilical skin, necrotizing enterocolitis (NEC) with advanced degrees of evolution (Bell stage > 2), congenital malformations and intravenous lines for parenteral feeding. Some cases received probiotics as a preventive measure against the possibility of NEC or sepsis [30][31][32][33][34][35] . In cases of preschool or school age children and in adults in whom invasion to the bloodstream by Bifidobacterium was detected, some were affected by tumors or haf been subjected to antitumor therapies.…”

Section: Casei L Plantarum L Acidophilus L Delbruecki Subsp Bumentioning

confidence: 99%

Inocuidad, prevención y riesgos de los probióticos

Brunser

2017

Rev. chil. pediatr.

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Probiotics have been defined as live microorganisms which, when ingested in adequate numbers, confer health benefits to the host. They are currently consumed without any age restrictions and adverse effects such as sepsis, a marker of the risk of invasion of the bloodstream, are extremely infrequent. However, some health professionals express doubts about probiotics being truly innocuous. This review discusses the incidence of sepsis secondary to probiotics use, mainly lactobacilli and bifidobacteria, evaluated through molecular biology or classic culture techniques, showing that sepsis in large numbers of individuals along decennia is extremely low, of the order of 0,02% en some centers or as low as 1 case/million population in France. These data are important considering the use different species and strains of these microorganisms. Few studies which have reported other adverse effects but many of these have problems with their design that cast doubt about the validity of their results. On the contrary, it has been shown that probiotic microorganisms exert positive stimulatory effects on innate and acquired immunity, with decrease of the manifestations of atopy and eczema. These positive effects are further evidenced by the beneficial effects of many species of probiotics in preventing necrotizing enterocolitis in patients as functionally labile as premature-born babies.

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Bifidobacterium Septicemia Associated with Postoperative Probiotic Therapy in a Neonate with Omphalocele

Cited by 143 publications

References 10 publications

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial

A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infantS (PiPS) trial

Inocuidad, prevención y riesgos de los probióticos

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