A trial in which intensive care patient on a ventilator will be given the probiotic E.coli Nissle in order to establish whether this organism can colonise the stomach.
- Conditions
- Gastric colonisation by pathogenic gram negative bacteria in ventilated adult ICU patients and it's prevention by the probiotic E.coli Nissle 1917Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]
- Registration Number
- EUCTR2011-002343-99-GB
- Lead Sponsor
- Heart of England NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
We will recruit a total of 60 patients from the Heart of England NHS Foundation Trust critical care units, using a non-treatment group as the control. Patients =18 years that have been intubated for =24 hours and who are expected to require mechanical ventilation with a tracheal tube or tracheostomy for =48 hours will be considered for enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
The following exclusion criteria will apply: 1. Imminent treatment withdrawal 2. Designated consultee does not provide assent 3. Pregnancy or lactation 4. Therapy with immunosuppressants 5. Absolute neutrophil count =500/mm3 6. Gastrointestinal bleeding 7. Prosthetic cardiac valve or vascular graft 8. Cardiac trauma 9. History of rheumatic fever, endocarditis or congenital heart disease 10.Contraindication to enteral feeding 11.Gastro-oesophageal or intestinal injury or foregut surgery during the current admission 12.Acute pancreatitis 13.Participation in a CTIMP within the last 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if the probiotic E.coli Nissle will colonise the stomach of ventilated (on a breathing machine)intensive care patients after it is administered directly into the stomach via a nasogastric tube (tube going from nose into stomach).;Secondary Objective: 1.To determine the optimum dose of E.coli Nissle that needs to be administered in order to achieve this. 2.To determine the time to gastric colonisation(if successful). 3.To determine if there is a difference in the colonisation rates with potentially harmful bacteria between patients who receive E.coli Nissle and those who don't.. 4.To determine if there is a difference in the rates of ventilator-associated pneumonia between patients who receive E.coli Nissle and those who don't.;Primary end point(s): This is a proof of principle study. The primary outcome will be demonstration of successful gastric colonisation by E.coli Nissle in ventilated ICU patients.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Data will be collected during the time the patient remains on a ventilator. The overall end point for each patient will be 90 day mortality or the time to hospital discharge if this is later.;Secondary end point(s): 1. Incidence of gastric and oropharyngeal colonisation by opportunistic pathogenic GNB after administration of probiotic. 2. Time of the first gastric colonisation by opportunistic pathogenic Gram-negative bacteria. 3. Time of the first tracheal colonisation by opportunistic pathogenic Gram-negative bacteria 4. Cumulative incidence of ICU-acquired infection 5. Number of ventilator free days up to day 28 after randomisation 6. Number of antibiotic free days up to day 28 after randomisation 7. ICU length of stay 8. Hospital length of stay 9. ICU mortality 10.Hospital mortality 11.28 & 90-day mortality