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 Hospital0 个研究点目标入组 40 人开始时间: 2024年1月16日最近更新: 2024年1月22日

适应症

试验速览

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•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.

•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

发起方

South Metropolitan Health Service - Fiona Stanley Hospital