tolerance,safety,and effect on the faecal microbiota of an
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Probiotics WHO definition
"Live microorganismswhich when administered
in adequate amounts confer a health benefit on
the host
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Be of human source
Nonpathogenic
Resist gastric, bile, pancreatic digestion
Adhere to and colonize the enterocytes
Produce antimicrobial substances
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xLactobacilli
xBifidobacteria
xSaccharomyces boulardii(yeast)
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Prebiotics
Definition : Prebiotic is a non-viable
food component that confers a healthbenefit on the host associated with
modulation of the microbiota
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Example
x fructo- and galacto-oligosaccharides
x Inulin
x psyllium
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Tolerance, Safety, and Effect on the
Faecal Microbiota of an Enteral Formula
Supplemented With Pre-and Probioticsin Critically Ill Children
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The aim of this study was to demonstrate
the toleranceand safety of an
enteralformula containingprebiotics/probiotics, and its effect on
the faecal microbiota in critically ill
children
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Study Design Randomized controlled trial
double-blind
2 parallel patient groups
In 2 medical centers
xMaharat Nakhon Ratchasima Hospital
x KhonKaen Hospital
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Critically ill patients age 1 and 3 years
Admission in PICU
Between August 2006-May 2009
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Patients experiencing
Pneumonia
NeurologicalCardiovascular disease
Need of mechanical ventilation
Need of Enteral nutrition(EN)
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Overt GI bleeding
Anatomic obstructions of the GI
Recent oesophageal or GI surgery Immunodeficiency
GI disorders that would affect enteral
feeding
(eg,malabsorption, intestinal dysmotility)
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Products provided in metallic tins and
distinguished by 2 different colours and
letterlabels A:yellow B:blue
The identity of the products was blind to
the subjects, support staff, andinvestigators
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Group 1 (Treatment group) Enteral formular
2 Probiotics strain
x L paracasei 5x106CFU/g
x B longum 2x106CFU/g
Prebiotics
x Oligofructose/inulin 2.6g/L
xAcacia gum 2.8g/L
DHA 43mg/L
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Group 2 (Control ) same enteral formula
No pre-and probiotics or DHA
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Both products isocaloric and isoproteic
and consisted of proteins, carbohydrates, fats,
vitamins, and minerals in amounts Intended for
the full nutritional support of critically ill
patients.
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Daily energy intake Set at 70 kcal/kg/day
Daily intake of probiotics 109 CFU
Daily intake of prebiotics
3.8 g
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Gastric residual volume (GRV) Recorded before the administration of each of
the following boluses
Tolerance markers Abdominal distension, episodes of vomiting and
diarrhoea
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FaecalSampleCollection At admission in the ICU(day1)
Discharge from the ICU(day7)
Post admission 14 days
Processed within 30 minute safte
remission
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L paracasei, B longum : detect by partial
genome sequence
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Demographic Characteristics Mean age was 1.98+0.95 yrs
Mean weight was 10.29+2.55 kg
PRISM score was 0.0+2.4,
and 3 subjects had a score > 8
82 % of the subjects were under Antibiotic
treatmentat
100% and 95.7% of the patients from the test and
control groups received antibiotics during
hospitalisation
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Demographic Characteristics
Pneumonia71.3%Neurological diseases 17%,
Combined pneumonia and neurological
diseasesin 7.4%
Combined pneumonia andcardiovascular 3.2%
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Caloric in take during the hospitalisation Similar between the 2 formulae
Test group 76% - control group 75%
Abdominal distension Similar in the 2 groups (P=0.83)
Test group 42cm - control group 43cm
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Vomiting Similar in the 2 groups
Test group 21.3% - control group 25.5%(12)
Diarrhoeal Similar in the 2 groups
Test group 2.6% - control group 34%(16)
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Bifidobacterial Clear drop in first week
Followed by recovery in the second week
only in the test group
Suspect that the increase in the total
bifidobacterial population was
related to the fibres included in theformula rather probiotic counts
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Vancomycin-resistant enterococci Pathogenic members of the Enterobacteriaceae
family
Baseline
x Test Group : Mean+SD of 42%+39.9%
x Control Group : Mean+SD of 47%+36.5%
At the end of study
x Test Group : Mean+SD of38%+40%
x Control Group : Mean+SD of51%+37%
x No statistically significant P=0.12
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Most frequently reported category was
GI disorders, particularly Diarrhoea
No secondary infections during the ICU
stay
No signifi cant differences between
groups
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Enteral feeding and Antibiotic can
profoundly disturb the ecological
homeostasis in patients in the ICU
The disruption of the gut microbiota has
a relevance to the final outcome in
critically ill patients
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Both can resist passage through the GI tract
L paracasei NCC 2461 efficacy for the management of bacterial infectious
diarrhoea in children
results tolerance and safety in full-term infants
B longum NCC 3001
associated with improvement of GI discomfortinduced by antibiotics
No adverse events were recorded
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Enteral formula supplemented withSynbiotcs was safe and well tolerated inpatients from PICUs
Bifidobacteria and Lactobacilli previouslyreported beneficial effects
This studyshould encourage the design of
future clinical trials powered enough tounequivocally determine their clinicalbenefits
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Method of study
Randomize controlled trial
Double blind
Was the assignment of patients totreatments randomized?
Yes
Was the randomization list concealed?Yes
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Were ll tients entered t e tri lnted f r t its ncl si n?
Test grEnr llment = 47
Wit dr = 1
L ss F/U = 1
Dead = 4
Analize = 41
C ntr l grEnr llment = 47
Wit draw = 5
L ss F/U = 1
Dead = 2
Analize = 39
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Were the groups similar at the start
of the trial?
Yes
No significant differences in baselinecharacteristics between 2 groups
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Were the patients in all groups followedup and data collected in the same way?Yes
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Outcome measured in a reasonable way :
subjective & objective ?
Yes
Score of validity (0-10) : 10
Overall validity? : Accept
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Yes
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Is your patient so different from those in the
study that its results cannot apply?
- No different
indifference in Race, Economic agegroup, disease, wether
Is the treatment feasible in your setting? Yes
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Thank You