Delving into the Latest Updates on Spores of Bacillus Clausii Probiotic Strain(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Probiotics

Synonyms-

Target-

Action

modulators

Mechanism

Bacteria replacements, Microbiome modulators

Therapeutic Areas

Other Diseases

Active Indication-

Inactive Indication

Acute diarrhea

Originator Organization

Sanofi

Active Organization-

Inactive Organization

Sanofi

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Primary Objective:
o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
Secondary Objectives:
To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
To assess the efficacy of the probiotics on the disease severity.
To assess the safety and tolerability of the studied probiotics.

Start Date19 Jun 2017

Sponsor / Collaborator

Biocodex SAS

NCT00265369

/ CompletedPhase 3

Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children

Primary objective:
To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.

Start Date01 May 2004

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Spores of Bacillus Clausii Probiotic Strain(Sanofi)

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100 Translational Medicine associated with Spores of Bacillus Clausii Probiotic Strain(Sanofi)

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100 Patents (Medical) associated with Spores of Bacillus Clausii Probiotic Strain(Sanofi)

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Literatures (Medical) associated with Spores of Bacillus Clausii Probiotic Strain(Sanofi)

01 Oct 2015·Journal of Tropical PediatricsQ4 · MEDICINE

Bacillus clausiifor Prevention of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial

Q4 · MEDICINE

Article

Author: Tewari, Vishal Vishnu ; Gupta, Girish ; Dubey, Sachin Kumar

BACKGROUND OF THE STUDYPreterm infants are managed with antibiotics for sepsis, including suspected or probable sepsis. This leads to a delayed and abnormal colonization of the gut with potentially pathogenic organisms and a microbiome, which lacks biodiversity and increases the risk for late-onset sepsis (LOS). Probiotics have been proven to reduce the risk for necrotizing enterocolitis, but evidence for prevention of LOS is inconclusive. Probiotic effect depends also on the strain used, dose and indication for use. This study evaluated Bacillus clausii probiotic administered prophylactically to preterm neonates for prevention of LOS.OBJECTIVESTo study B.clausii given prophylactically to preterm neonates for prevention of LOS.DESIGNDouble-blinded, placebo-controlled, randomized trial.SETTINGSTertiary care neonatal unit in India.PARTICIPANTSConsecutive preterm neonates <34 weeks, admitted from 1 March 2012 to 28 February 2014 were stratified as extreme preterm and very preterm.INTERVENTIONRandomized to receive either probiotic or placebo for 6 weeks, discharge from hospital, death or occurrence of sepsis, whichever was earlier.PRIMARY OUTCOMEIncidence of definite and probable LOS in probiotic group compared with placebo.RESULTSOf 326 eligible preterm infants, 244 were enrolled and 82 were excluded. Of these, 120 were stratified as extreme preterm and randomized to receive placebo (n = 59) and probiotic (n = 61). Of 124 babies stratified as very preterm, an equal number was randomized to receive placebo (n = 62) and probiotic (n = 62). There was no significant difference in the incidence of LOS between the two arms in the extreme preterm group [29% vs. 23%; relative risk (RR) 1.27; 95% confidence interval (CI) 0.88-1.66; p = 0.36] and the very preterm group (13% vs. 10%; RR 1.33; 95% CI 0.96-1.70; p = 0.32). Full feeds were achieved significantly faster in the probiotic group in both the extreme preterm (RR 0.82; 95% CI 0.74-0.88) and the very preterm (RR 0.67; 95% 0.32-0.77).CONCLUSIONSProphylactic administration of B.clausii to preterm neonates did not result in a significant difference in the incidence of LOS as compared with placebo.

100 Deals associated with Spores of Bacillus Clausii Probiotic Strain(Sanofi)

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