tolerance,safety,and effect on the faecal microbiota of an

8/4/2019 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

tolerance,safety,and effect on the faecal microbiota of an

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