VSL#3

• Research type

  Research Study

• Full title

  The effect of probiotics on the incidence of spontaneous bacterial peritonitis in patients with cirrhosis and ascites.

• IRAS ID

  59704

• Contact name

  Martin James

• Sponsor organisation

  Nottingham University Hospital NHS Trust

• Eudract number

  2010-022886-92

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of the study is to investigate whether oral probiotics (VSL#3 sachets) or antibiotics (co-trimoxazole) reduce the incidence and severity of liver-related end points (mortality and morbidity) in patients with cirrhosis (scarring of the liver as a result of chronic liver disease) and ascites fluid retention in the abdominal cavity which occurs as a result of liver cirrhosis). The study will examine the effect of probiotics and antibiotics on the incidence and severity of infection in the abdominal cavity (Spontaneous Bacterial Peritonitis (SBP) and non-SBP infection), pressure in the portal vein which, when high can lead to bleeding and confusion (encephalopathy). The study will also assess whether primary prevention of liver related endpoints with probiotics or antibiotics affects the incidence of C.difficile infection in this group of patients.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  10/H0405/81

• Date of REC Opinion

  20 Dec 2010

• REC opinion

  Further Information Favourable Opinion