ROCIT

Funding

Charities/Societies/Foundations,Australian Red Cross Lifebood (ARCL)

Scientific enquiries

Dr Fionnuala Murray

Brief Summary

In this prospective, 2 stage interventional pilot study we aim to evaluate the safety and feasibility of FMT as a therapeutic intervention for dysbiosis associated with persistent critical illness, in patients who have been admitted to the intensive care unit (ICU) at a tertiary hospital in Western Australia. Subsequent preliminary evaluations of the efficacy of FMT at restoration of microbial diversity, richness and evenness in the recipient together with important clinical outcomes including t .... In this prospective, 2 stage interventional pilot study we aim to evaluate the safety and feasibility of FMT as a therapeutic intervention for dysbiosis associated with persistent critical illness, in patients who have been admitted to the intensive care unit (ICU) at a tertiary hospital in Western Australia. Subsequent preliminary evaluations of the efficacy of FMT at restoration of microbial diversity, richness and evenness in the recipient together with important clinical outcomes including the incidence of infection and burden of MDRO colonisation will be secondary endpoints.
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Key Inclusion Criteria

i) Age 18 years or older. ii) Inpatient in ICU for minimum of 96 hours who have an ongoing requirement for ICU at the time of enrolment iii) Received a minimum of 24 hours of broad-spectrum antimicrobials in the week preceding enrolment and not anticipated to require ongoing broad-spectrum antibiotics within 24 hours prior to FMT iv) Evidence of persistent organ dysfunction as defined by at least one of i) ongoing ventilatory support [high flow nasal prong oxygen, non-invasive ventilation, mecha .... i) Age 18 years or older. ii) Inpatient in ICU for minimum of 96 hours who have an ongoing requirement for ICU at the time of enrolment iii) Received a minimum of 24 hours of broad-spectrum antimicrobials in the week preceding enrolment and not anticipated to require ongoing broad-spectrum antibiotics within 24 hours prior to FMT iv) Evidence of persistent organ dysfunction as defined by at least one of i) ongoing ventilatory support [high flow nasal prong oxygen, non-invasive ventilation, mechanical ventilation], ii) persistent renal dysfunction as defined by KDIGO guidelines (need for RRT or persistent Cr greater than x1.5 premorbid baseline or persistent UO less than 0.5ml/kg/hr, iii) persistent vasoactive requirement v) Established on and tolerating enteral feeds of at least 30ml/h via nasogastric tube for a minimum of 24hours with 4 hourly residual aspirates consistently less than 300ml in the last 24 hours.
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Key Exclusion Criteria

i)Patients with established concurrent indications for FMT including C. difficile infection and inflammatory bowel disease (IBD). ii)Subjects with compromised immune system, including: (a) Absolute neutrophil count (ANC) of less than 0.5 x 109 cells / L within 7 days of enrolment or sustained AN less than 1 x 109 cell / L., (b) Subjects on active chemotherapy or monoclonal therapy targeting B or T cells, glucocorticoids > 10mg prednisolone daily or equivalent for greater than or equal to 2 weeks .... i)Patients with established concurrent indications for FMT including C. difficile infection and inflammatory bowel disease (IBD). ii)Subjects with compromised immune system, including: (a) Absolute neutrophil count (ANC) of less than 0.5 x 109 cells / L within 7 days of enrolment or sustained AN less than 1 x 109 cell / L., (b) Subjects on active chemotherapy or monoclonal therapy targeting B or T cells, glucocorticoids > 10mg prednisolone daily or equivalent for greater than or equal to 2 weeks (with the exception of inhaled or topical glucocorticoids which are permitted), recent bone marrow transplant [within 8 weeks], uncontrolled HIV [CD4 count less than 240 cells/mm3], anti-TNF therapy. iii) Subjects who are pregnant or lactating. iv) Previous FMT or microbiome-based therapeutics (exception: the use of over-the-counter probiotics). v) Subjects with severe, life-threatening food allergies vi) Subjects with established contra-indication to PPI administration. vii) Subjects with contraindication to both metoclopramide and domperidone use. viii) Inability to maintain head of participants bed at greater than 30-degree angle for 4 hours post NG administration of FMT product. ix) The treating clinical believes that trial participation is not in the best interest of the patient x) The treating clinician believes death is inevitable AND the clinician, next-of-kin or patient are not committed to ongoing active treatment
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