scholarly journals Effects of oral probiotic supplementation on gut Lactobacillus and Bifidobacterium populations and the clinical status of low-birth-weight preterm neonates: a multicenter randomized, double-blind, placebo-controlled trial

2018 ◽  
Vol Volume 11 ◽  
pp. 1557-1571 ◽  
Author(s):  
Magdalena Strus ◽  
Ewa Helwich ◽  
Ryszard Lauterbach ◽  
Beata Rzepecka-Węglarz ◽  
Katarzyna Nowicka ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Controlled Trial ◽  
Clinical Status ◽  
Preterm Neonates ◽  
Probiotic Supplementation ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0–2-month-old low birth weight infants in India—the “ProSPoNS” Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anju Pradhan Sinha ◽  
◽  
Subodh S. Gupta ◽  
Ramesh Poluru ◽  
Abhishek V. Raut ◽  
...  
Keyword(s):  
Birth Weight ◽  
High Risk ◽  
Low Birth Weight ◽  
Research Ethics ◽  
Neonatal Sepsis ◽  
Phase Iii ◽  
Low Birth Weight Infants ◽  
Probiotic Supplementation ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising. Methods A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites. Discussion This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low–middle-income countries. Trial registration Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019

scholarly journals Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind, placebo-controlled trial

2009 ◽  
Vol 89 (6) ◽  
pp. 1828-1835 ◽  
Author(s):  
Carole Rougé ◽  
Hugues Piloquet ◽  
Marie-José Butel ◽  
Bernard Berger ◽  
Florence Rochat ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Preterm Infants ◽  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Supplementation

scholarly journals Evaluating the Efficacy of a Multistrain Probiotic Supplementation for Prevention of Neonatal Sepsis in 0-2 Months Old Low Birth Weight Infants in India – The ‘ProSPoNS’ Study Protocol for a Phase III, Multicentric, Randomized, Double-Blind, Placebo-Controlled Trial.

2021 ◽  
Author(s):  
Anju Pradhan Sinha ◽  
Subodh S Gupta ◽  
Ramesh Poluru ◽  
Abhishek V Raut ◽  
Narendra K Arora ◽  
...  
Keyword(s):  
Birth Weight ◽  
High Risk ◽  
Low Birth Weight ◽  
Research Ethics ◽  
Neonatal Sepsis ◽  
Phase Iii ◽  
Low Birth Weight Infants ◽  
Probiotic Supplementation ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background: Progress has been made in reduction of under five mortality in India, however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the SDG-3. Prevention of sepsis among the high risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising.Methods/design: A phase III, multicentre, randomized, double blind, placebo-controlled is being conducted at six sites in India. A total of 6144 Healthy LBW infants fulfilling the eligibility criteria would be enrolled within first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex and birth weight would be done through an interactive web response system (IWRS) using a standard web browser and email service Vivomixx R a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1ml/day dose for 30 days. The follow-up of enrolled infants would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performingsepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. Study would be implemented as per the MRC guideline for management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A Contract Research Organization would be enaged for comprehensive monitoring and quality assurance. . The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes sepsis, possible serious Bacterial Infection (PSBI) & secondary outcomes. The codes will be broken after DMEC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sitesDiscussion: This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high risk group of Low Birth Weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital based studies and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other Low–middle income countries.Trial registration: The study is registered at the Clinical Trial Registry of India (CTRI; 1 http://ctri.nic.in); Number CTRI/2019/05/019197, date 16 May 2019).

scholarly journals Probiotics to prevent necrotising enterocolitis and nosocomial infection in very low birth weight preterm infants

2017 ◽  
Vol 117 (7) ◽  
pp. 994-1000 ◽  
Author(s):  
J. Uberos ◽  
E. Aguilera-Rodríguez ◽  
A. Jerez-Calero ◽  
M. Molina-Oya ◽  
A. Molina-Carballo ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Very Low Birth Weight ◽  
Late Onset ◽  
Necrotising Enterocolitis ◽  
Stage Ii ◽  
Preterm Neonates ◽  
Probiotic Supplementation ◽  
Late Onset Sepsis ◽  
Reduced Risk

AbstractThe aim of the study was to determine whether routine probiotic supplementation (RPS) with Lactobacillus rhamnosus GG (LGG) or Lactobacillus acidophilus +Lactobacillus bifidum is associated with reduced risk of necrotising enterocolitis (NEC)≥Stage II in preterm neonates born at ≤32 weeks’ gestation. We conducted a retrospective cohort study on the effect of probiotic supplementation in very low birth weight infants in our neonatal unit by comparing two periods: before and after supplementation. The incidence of NEC≥Stage II, late-onset sepsis and all-cause mortality was compared for an equal period ‘before’ (Period I) and ‘after’ (Period II) RPS with LGG or L. acidophillus+L. bifidum. Multivariate logistic regression analysis was conducted to adjust for relevant confounders. The study population was composed of 261 neonates (Period I v. II: 134 v. 127) with comparable gestation duration and birth weights. In <32 weeks, we observed a significant reduction in NEC≥Stage II (11·3 v. 4·8 %), late-onset sepsis (16 v. 10·5 %) and mortality (19·4 v. 2·3 %). The benefits in neonates aged ≤27 weeks did not reach statistical significance. RPS with LGG or L. acidophillus+L. bifidum is associated with a reduced risk of NEC≥Stage II, late-onset sepsis and mortality in preterm neonates born at ≤32 weeks’ gestation.

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