Restoration of gut microbiota in Persistent Critical illness using Faecal Microbiota Transplantation (The ROCIT-FMT Trial): a pilot phase I/II trial

Phase 1

• Conditions: Persistent Critical Illness; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Other respiratory disorders / diseases; Renal and Urogenital - Other renal and urogenital disorders; Cardiovascular - Other cardiovascular diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000034538
• Lead Sponsor: South Metropolitan Health Service - Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-16
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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, 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 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 (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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i)Safety of FMT via NG administration in ICU patients with evidence of PerCI, as assessed by the incidence of grade 3-5 FMT-related adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. FMT will be considered unsafe in critically ill patients when there are definitely FMT-related SAE in >1 participant.<br>- data will be collected from electronic medical records[ Baseline, Day 5, Day 7, Day 30 post FMT administration.]