The effect of probiotics on the incidence of spontaneous bacterial peritonitis in patients with cirrhosis and ascites. - VSL#3

Phase 1

• Conditions: cirrhosis and hepatic failure

• Registration Number: EUCTR2010-022886-92-GB
• Lead Sponsor: ottingham University Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-17
• Study Completion: 2014-10-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

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 and ECG within 14 days of enrolment.

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

Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 or is inappropriate for placebo medication

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Do oral probiotics (VSL#3 sachets)or oral antibiotics (cotrimoxazole) reduce the incidence and severity of liver-related complications in cirrhotic patients with ascites?;Secondary Objective: To investigate the effect of probiotics or antibiotics on the incidence of infection in the abdominal cavity (Spontaneous Bacterial Peritonitis (SBP, non-SBP sepsis, variceal bleeding and encephalopathy. The study also aims to examine whether the incidence of C .difficile (antibiotic associated diarrhoea) is affected by either the use of antibiotics or probiotics.;<br> Primary end point(s): Overall Liver-related mortality and Liver-related morbidity.<br>