VSL#3 and Spontaneous Bacterial Peritonitis

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Research question: Do oral probiotics in patients with cirrhosis and ascites reduce intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to antibiotics or placebo?

This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of "healthy" bacteria for the intestines) compared to an antibiotic or placebo in preventing infection developing in the abdominal fluid ("ascites") that collects in patients with advanced liver disease ("cirrhosis"). Patients already having had infection will be excluded from the study. Clear inclusion and exclusion criteria will be met and patients will be monitored throughout the study to examine whether they have required more hospitalisations, their rate infection in abdominal fluid or elsewhere and the level of liver function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nottingham University Hospitals NHS Trust
• Collaborator: VSL Pharmaceuticals
• Treatments: Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion criteria:

• Participant is willing and able to give informed consent for participation in the study.

• Male or Female, aged 18 years or above.

• Diagnosed with required disease/severity/symptoms as outlined in 6.3.1.

• Stable dose of current regular medication (e.g. diuretics, beta-blockers, vitamin supplementation) for at least 4 weeks prior to study entry.

• Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter

• Participants have clinically acceptable laboratory tests and ECG within 14 days of enrolment.

• Able (in the Investigators opinion) and willing to comply with all study requirements.

Willing to allow their General Practitioner and consultant

Exclusion criteria:

• Female participants who is pregnant, lactating or planning pregnancy during the course of the study.

• Presence of hepatocellular carcinoma

• Scheduled elective surgery or other procedures requiring general anaesthesia during the study.

• Participant who is terminally ill

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

• Use of antibiotics or probiotics in the last 2 weeks

• Known hypersensitivity to trimethoprim, sulphonamides or any other ingredients in co-trimoxazole tablet.

• History of acute porphyria or serious haematological disorder.

• Participants who have participated in another research study involving an investigational product in the past 12 weeks