Trial reportBMJ open2015
Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial.
Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 8 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Bifidobacterium infantis as a probiotic in preterm infants: a systematic review and meta-analysis.Pediatric research · 2023Pooled it
- Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants.The Cochrane database of systematic reviews · 2023Pooled it
- Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants.The Cochrane database of systematic reviews · 2020Pooled it
- AGA Technical Review on the Role of Probiotics in the Management of Gastrointestinal Disorders.Gastroenterology · 2020Guideline
- Probiotics Reduce Mortality and Morbidity in Preterm, Low-Birth-Weight Infants: A Systematic Review and Network Meta-analysis of Randomized Trials.Gastroenterology · 2020Pooled it
- Pooled it
- Pooled it
- Probiotics Prevent Late-Onset Sepsis in Human Milk-Fed, Very Low Birth Weight Preterm Infants: Systematic Review and Meta-Analysis.Nutrients · 2017Pooled it
- Trial
- A Review of Probiotic Interventions for Necrotizing Enterocolitis and Sepsis in Preterm Infants.International journal of molecular sciences · 2026Review
- Role of central endpoint adjudication and challenges in trials on neonatal sepsis-a case of ProSPoNS trial.Trials · 2024Article
- Effects of Perinatal Antibiotic Exposure and Neonatal Gut Microbiota.Antibiotics (Basel, Switzerland) · 2023Review
- Utilization of a High Potency Probiotic Product for Prevention of Necrotizing Enterocolitis in Preterm Infants at a Level IV NICU.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Article
- Effects of neonatal nutrition interventions on neonatal mortality and child health and development outcomes: A systematic review.Campbell systematic reviews · 2021Review
- Review
- A Summary of the Fifth Annual Virology Education HIV Microbiome Workshop.AIDS research and human retroviruses · 2020Article
- Understanding the Elements of Maternal Protection from Systemic Bacterial Infections during Early Life.Nutrients · 2020Review
- Therapeutic Microbiology: The Role ofNutrients · 2018Review
- The importance of the microbiome in pediatrics and pediatric infectious diseases.Current opinion in pediatrics · 2018Review
Corrections and comments
- Commented on by
Authors and funding
15 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants.
designRandomised, double-blind, placebo-controlled trial.
settingCommunity setting in rural India.
participantsLBW infants aged 3-7 days.
interventionsInfants 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 measurePossible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians.
results668 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).
conclusionsDaily 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).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.