Efficacy and dosing of probiotic E.coli in gastric colonisation(V1.0)

• Research type

  Research Study

• Full title

  An Open-label Study into the Efficacy and Dosing of Probiotic Escherichia coli Nissle 1917 for Prevention of Gram-negative Gastric Colonisation in Ventilated Intensive Care Patients.

• IRAS ID

  79764

• Contact name

  Fang Gao

• Sponsor organisation

  Heart of England NHS Foundation Trust

• Eudract number

  2011-002343-99

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Probiotics are live bacteria which are thought to have a beneficial effect on the host organism. E.coli Nissle (ECN) is one such probiotic. Other examples of well-known probiotics include Lactobacilli - the product Yakult© contains Lactobacillus casei Shirota. E.coli Nissle is marketed in the United States, Germany and Canada for the treatment of inflammatory bowel disease and is available to buy from a pharmacy in these countries. We would like to use E.coli Nissle in a study to determine if it will have beneficial effects in Intensive Care Unit (ICU) patients who are critically ill. When patients are critically ill e.g. with a serious infection, after surgery or after a serious injury they may be put on a ventilator (breathing machine/life-support machine). This means that they will have a breathing tube going from the mouth into the trachea windpipe). While patients are on ICU, bacteria which are normally present in the stomach may change to other bacteria which have the potential to cause infection. This change occurs because of treatment with antibiotics and other medications used to prevent stomach ulcers. In some cases, these bacteria can move from the stomach into the lungs (aspiration) and lead to pneumonia. This is known as a ventilator-associated pneumonia (VAP). VAP will need to be treated with further antibiotics. The bacteria causing these infections are becoming resistant to the antibiotics currently available and the supply of new antibiotics is very limited. For this reason we urgently need new strategies to reduce or prevent infections. E.coli Nissle is a ??friendly? probiotic bacteria that competes with other bacteria in the stomach. We hope that giving by E.coli Nissle to patients on a breathing machine we will reduce or prevent the number of harmful bacteria in the stomach, and therefore reduce their chance of developing a ventilator-associated pneumonia.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  11/SC/0423

• Date of REC Opinion

  3 Jan 2012

• REC opinion

  Further Information Favourable Opinion