Invasively mechanically ventilated >72 hours at the time of screening;
Patients at potential increased risk of iatrogenic probiotic infection (see Section 2.6 for detailed explanation) including specific immunocompromised populations (HIV <200 CD4 cells/µL, those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2), previous transplantation (including stem cell) at any time, malignancy requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count < 500]). However, patients receiving corticosteroids previously or presently or projected to receive corticosteroids are not excluded;
Patients at risk for endovascular infection (previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material [mechanical or bio-prosthetic cardiac valves], previous or current endocarditis, permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts), tunnelled (not short-term) hemodialysis catheters, pacemakers or defibrillators. Patients with temporary central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs) are not excluded and patients with coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded; patients with mitral valve prolapse or bicuspid aortic valve are not excluded providing they have no other exclusion criteria;
Patients with a primary diagnosis of severe acute pancreatitis, without reference to a Ranson score [Ranson 1974]). However, patients with mild or moderate pancreatitis are not excluded;
Patients with percutaneous gastric or jejunal feeding tubes already in situ as per Health Canada guidance;
Strict contraindication or inability to receive enteral medications;
Intent to withdraw advanced life support as per the ICU physician;
Previous enrolment in this or current enrolment in a potentially confounding tria

NCT02462590_exc_T1
Procedure
mechanically ventilated
NCT02462590_exc_T2
Temporal
>72 hours
NCT02462590_exc_T3
Observation
risk of iatrogenic probiotic infection
NCT02462590_exc_T4
Condition
immunocompromised
NCT02462590_exc_T5
Condition
HIV
NCT02462590_exc_T6
Measurement
CD4
NCT02462590_exc_T7
Value
200 ells/µL,
NCT02462590_exc_T8
Procedure
immunosuppressive medications
NCT02462590_exc_T9
Qualifier
chronic
NCT02462590_exc_T10
Drug
azathioprine
NCT02462590_exc_T11
Drug
cyclosporine
NCT02462590_exc_T12
Drug
cyclophosphamide
NCT02462590_exc_T13
Drug
tacrolimus
NCT02462590_exc_T14
Drug
methotrexate
NCT02462590_exc_T15
Drug
mycofenolate
NCT02462590_exc_T16
Drug
Anti-IL2
NCT02462590_exc_T17
Scope
azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2
NCT02462590_exc_T18
Procedure
transplantation
NCT02462590_exc_T19
Procedure
chemotherapy
NCT02462590_exc_T20
Temporal
last 3 months
NCT02462590_exc_T21
Condition
neutropenia
NCT02462590_exc_T22
Measurement
absolute neutrophil count
NCT02462590_exc_T23
Value
< 500]
NCT02462590_exc_T24
Scope
immunocompromised populations (HIV <200 CD4 cells/µL, those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2), previous transplantation (including stem cell) at any time, malignancy requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count < 500])
NCT02462590_exc_T25
Observation
risk for endovascular infection
NCT02462590_exc_T26
Condition
rheumatic heart disease
NCT02462590_exc_T27
Condition
congenital valve disease
NCT02462590_exc_T28
Condition
congenital heart disease
NCT02462590_exc_T29
Qualifier
surgically repaired
NCT02462590_exc_T30
Condition
cyanotic congenital heart disease
NCT02462590_exc_T31
Qualifier
unrepaired
NCT02462590_exc_T32
Procedure
intracardiac repair
NCT02462590_exc_T33
Device
prosthetic material
NCT02462590_exc_T34
Device
bio-prosthetic cardiac valves]
NCT02462590_exc_T35
Device
chanical o rdiac valves],
NCT02462590_exc_T36
Scope
mechanical or bio-prosthetic cardiac valves
NCT02462590_exc_T37
Condition
endocarditis
NCT02462590_exc_T38
Device
endovascular devices
NCT02462590_exc_T39
Qualifier
permanent
NCT02462590_exc_T40
Device
endovascular grafts
NCT02462590_exc_T41
Procedure
aortic aneurysm repair
NCT02462590_exc_T42
Device
stents
NCT02462590_exc_T43
Qualifier
large arteries
NCT02462590_exc_T44
Device
inferior vena cava filters
NCT02462590_exc_T45
Device
dialysis vascular grafts
NCT02462590_exc_T46
Device
hemodialysis catheters
NCT02462590_exc_T47
Device
pacemakers
NCT02462590_exc_T48
Device
central venous catheters
NCT02462590_exc_T49
Device
central venous dialysis catheters
NCT02462590_exc_T50
Device
peripherally inserted central catheters
NCT02462590_exc_T51
Negation
not
NCT02462590_exc_T52
Negation
not
NCT02462590_exc_T53
Device
coronary artery stents
NCT02462590_exc_T54
Device
coronary artery bypass grafts
NCT02462590_exc_T55
Device
neurovascular coils
NCT02462590_exc_T56
Negation
not
NCT02462590_exc_T57
Condition
mitral valve prolapse
NCT02462590_exc_T58
Condition
bicuspid aortic valve
NCT02462590_exc_T59
Scope
mitral valve prolapse or bicuspid aortic valve
NCT02462590_exc_T60
Scope
coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils
NCT02462590_exc_T61
Device
PICCs
NCT02462590_exc_T62
Scope
central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs)
NCT02462590_exc_T63
Scope
endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts
NCT02462590_exc_T64
Scope
previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material [mechanical or bio-prosthetic cardiac valves], previous or current endocarditis, permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts), tunnelled (not short-term) hemodialysis catheters, pacemakers or defibrillators. Patients with temporary central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs) are not excluded and patients with coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded; patients with mitral valve prolapse or bicuspid aortic valve are not excluded providing they have no other exclusion criteria
NCT02462590_exc_T65
Condition
acute pancreatitis
NCT02462590_exc_T66
Qualifier
severe
NCT02462590_exc_T67
Negation
without
NCT02462590_exc_T68
Measurement
Ranson score
NCT02462590_exc_T69
Negation
not
NCT02462590_exc_T70
Condition
pancreatitis
NCT02462590_exc_T71
Qualifier
mild
NCT02462590_exc_T72
Qualifier
moderate
NCT02462590_exc_T73
Scope
mild or moderate
NCT02462590_exc_T74
Device
jejunal feeding tubes
NCT02462590_exc_T75
Device
ric or ing tubes alr
NCT02462590_exc_T76
Condition
contraindication
NCT02462590_exc_T77
Procedure
enteral medications