Necrotizing Enterocolitis Clinical Trial
Official title:
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates. Multi-centre, Randomised, Double-blind, Placebo-controlled Clinical Study.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its
influence on emergence and development of natural intestinal flora and the clinical status
of premature very low birth weight neonates. The study was also intended to investigate
reduction of colonisation by pathogenic bacteria and to estimate the incidence of
gastrointestinal disorders.
Probotic bacteria contained in the investigational product administered directly after birth
are beneficial for the development of normal gut microflora and can prevent or significantly
limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic
flora in a hospital setting. Permanent colonisation with commensal flora in very early life
improves gastrointestinal function in premature neonates by reducing the onset of or by
decreasing the severity of the signs and symptoms of feeding intolerance and generalised
bacterial infections, including sepsis and necrotizing enterocolitis.
Neonates defined as having very low birth weight (VLBW) are found to have a number of
conditions typical for this period of life and body weight at birth. Perinatal and neonatal
infections are relatively common in these babies, which can be attributed to their
immunological immaturity (immature cellular or humoral immune responsiveness) and
insufficient gastrointestinal tract colonisation by non-pathogenic bacteria, the presence of
which depends on the type of delivery, feeding and environment in which the neonates are
nursed.
Neonates admitted to neonatal intensive care units, particularly low birth-weight neonates
born prematurely or with congenital disorders, are most susceptible. Probiotics administered
to neonates are known to compete with pathogenic bacteria for essential nutrients and
receptor sites, and to enzymatically modify toxin receptors. They are also known to produce
antimicrobial substances, acidify the intestinal environment and stimulate the immune
system, helping it reach full maturity. These are the reasons why intestinal microflora
normalisation with the help of probiotics can be beneficial for VLBW neonates, especially
those requiring intensive medical care.
In a review of clinical studies on the use of probiotics in NEC prevention in neonates,
demonstrated beneficial effects of probiotics in a group of VLBW neonates compared to
placebo. There are scientific reasons to believe that probiotics administered to neonates
modulate the composition of the gut flora colonising the intestinal tract and are beneficial
for the development and maturity of the immune system. In hitherto clinical studies,
specific probiotic strains were found to provide beneficial effects by limiting infections
in the neonatal period, including necrotizing enterocolitis in VLBW neonates.
The purpose of this multicentre, randomized study was to investigate whether the use of a
probiotic preparation containing Lactobacillus rhamnosus KL53A and Bifidobacterium breve
PB04 influence on emergence and development of natural intestinal flora and the clinical
status of premature very low birth weight neonates and reduction of colonisation by
pathogenic bacteria and to estimate the incidence of gastrointestinal disorders. The study
took place between April 2012 and July 2013 in eight study centres in Poland. It was
conducted in accordance with the original protocol and according to ICH-GCP requirements.
The duration of subject's participation in the trial was approximately 49 days, or until
they were withdrawn or discharged from the hospital, whichever came earlier, prior to day
49.
As the trial did not concern medicinal product but the foodstuff (food for special medical
purpose) it did not require Authority approval but was only subject to relevant Ethics
Committee approval.
The study only included neonates who fulfilled the eligibility criteria, after obtaining an
informed consent from their parents/legal guardians, to have their baby enrolled in the
study and randomized into one of the two study groups: probiotic or placebo. Investigational
product were administered during the first 48h of life, at the time of the enteral feed.
Efficacy evaluation was to determine whether the investigational product positively
influences the emergence and progressive development of the natural gut flora and the
clinical status of preterm VLBW neonates. As part of the efficacy evaluation, it was also
examined whether the probiotic agent has the capacity to inhibit pathogenic colonisation and
to reduce the incidence of gastrointestinal disorders, as compared to placebo.
Safety was evaluated by determining whether investigational product in VLBW preterm neonates
increases AE/SAE incidence and influences the type of adverse events and serious adverse
events as compared to placebo.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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