Restoration of gut microbiota in Persistent Critical illness using Faecal Microbiota Transplantation (The ROCIT-FMT Trial): a pilot phase I/II trial
Restoration of gut microbiota in Persistent Critical illness patients using Faecal Microbiota Transplantation (The ROCIT-FMT Trial): a pilot phase I/II trial
South Metropolitan Health Service - Fiona Stanley Hospital
40 participants
Feb 1, 2024
Interventional
Conditions
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 the incidence of infection and burden of MDRO colonisation will be secondary endpoints.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria12
- 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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Interventions
Escalating doses of Australian Red Cross Lifeblood faecal microbiota transplant (FMT) product will be administered via nasogastric tube at pre-determined escalation infusion rates to participants who meet the eligibility criteria and provide informed consent. Initial dose will be 50g of FMT at a rate of 25ml/hr to initial 3 participants. The dose will then be escalated to 100g at 25ml/hr to the next 3 participants pending tolerability of the initial dose. The infusion rate will subsequently be escalated to 37.5ml/hr for the subsequent 3 participants. The final 3 participants in stage 1 will received 150g of FMT at a rate of 37.5ml/hr. Premedication with a proton pump inhibitor will be initiated at least 36 hours prior to FMT administration (i.e. 3 doses 12 hours apart to be received prior to FMT) and an anti-emetic agent will be initiated a minimum of 12 hours prior to intervention. Rectal swabs will be collected pre FMT administration (within 6 hours prior to planned administration) and at pre-determined timepoints (day 1, 5 and 7 post) after intervention by the registered bedside nursing staff.
Locations(1)
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ACTRN12624000034538