. .

Probiotics

WHO definition

"Live microorganisms which when administered in adequate amounts confer a health benefit on the host

 Be of human source Nonpathogenic Resist gastric, bile, pancreatic digestion Adhere to and colonize the enterocytes Produce antimicrobial substances

x Lactobacilli x Bifidobacteria x Saccharomyces boulardii (yeast)

 Prebiotics Definition

: Prebiotic is a non-viable food component that confers a health benefit on the host associated with modulation of the microbiota

 Example x fructo- and galacto-oligosaccharides x Inulin x psyllium

 Tolerance, Safety, and

Effect on the Faecal Microbiota of an Enteral Formula Supplemented With Pre-and Probiotics in Critically Ill Children

 The

aim of this study was to demonstrate the toleranceand safety of an enteralformula containing prebiotics/probiotics, and its effect on the faecal microbiota in critically ill children

 Study

Design

Randomized controlled trial double-blind 2 parallel patient groups In 2 medical centers x Maharat Nakhon Ratchasima Hospital x KhonKaen Hospital

 Critically

ill patients age 1 and 3 years Admission in PICU Between August 2006-May 2009

 Patients

experiencing Pneumonia Neurological Cardiovascular disease Need of mechanical ventilation Need of Enteral nutrition(EN)

 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)

 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, and investigators

 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 x Acacia gum 2.8g/L DHA 43mg/L

 Group

2 (Control )

same enteral formula No pre-and probiotics or DHA

 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.

 Daily Daily Daily

energy intake intake of probiotics intake of prebiotics

Set at 70 kcal/kg/day 109 CFU 3.8 g

 Advance

to the full caloric goal

20mL (or kcal) 40mL (or kcal) 60mL (or kcal) 70mL (or kcal)

Following algorithm was respected

Day1 Day2 Day3 Day4

= = = =

 Gastric

residual volume (GRV) markers

Recorded before the administration of each of

the following boluses

Tolerance

Abdominal distension, episodes of vomiting and

diarrhoea

 FaecalSampleCollection

At admission in the ICU(day1) Discharge from the ICU(day7) Post admission 14 days
Processed

within 30 minute safte

remission

paracasei, B longum : detect by partial genome sequence

 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

 Demographic

Characteristics

Pneumonia71.3% Neurological

diseases 17%, Combined pneumonia and neurological diseasesin 7.4% Combined pneumonia and cardiovascular 3.2%

 Caloric

in take during the hospitalisation distension

Similar between the 2 formulae Test group 76% - control group 75%
Abdominal

Similar in the 2 groups (P=0.83) Test group 42cm - control group 43cm

 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)

 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 the formula rather probiotic counts

 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 of 38%+40% x Control Group : Mean+SD of 51%+37% x No statistically significant P=0.12

 Enterobacteriaceae

and P aeruginosa Tested for ATB resistance

The

percentage of resistance to at least 1 antibiotic similar between the groups (57.4%;P=0.20)

 Most

frequently reported category was GI disorders, particularly Diarrhoea No secondary infections during the ICU stay No signifi cant differences between groups

 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

 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

induced by antibiotics

associated with improvement of GI discomfort

No

adverse events were recorded

 Enteral

formula supplemented with Synbiotcs was safe and well tolerated in patients from PICUs and Lactobacilli previously reported beneficial effects studyshould encourage the design of future clinical trials powered enough to unequivocally determine their clinical benefits

Bifidobacteria

This

 Method

of study

Randomize controlled trial Double blind

Was

the assignment of patients to treatments randomized?

Yes

Was

the randomization list concealed?

Yes

 Were

ll tients nted f r t its

entered t e tri l ncl si n?

C ntr l gr Enr llment = 47 Wit draw = 5 L ss F/U = 1 Dead = 2 Analize = 39

Test gr Enr llment = 47 Wit dr = 1 L ss F/U = 1 Dead = 4 Analize = 41

 Were

the groups similar at the start of the trial?

Yes No significant differences in baseline characteristics between 2 groups

 Were

the patients in all groups followed up and data collected in the same way?
Yes

 Outcome

measured in a reasonable way : subjective & objective ?

Yes

Score

of validity (0-10) : 10 Overall validity? : Accept

Yes

 Is

your patient so different from those in the study that its results cannot apply? - No different indifference in Race, Economic age group, disease, wether Is the treatment feasible in your setting?
Yes

Thank You