Prevention of infection in patients with cirrhosis with probiotic Lactobacillus casei Shirota
- Conditions
- CirrhosisDigestive System
- Registration Number
- ISRCTN62619436
- Lead Sponsor
- niversity College London
- Brief Summary
2020 Results article in https://doi.org/10.3390/nu12061651 (added 12/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 92
1. Patients aged between 18-78 years
2. Clinical and radiological evidence of cirrhosis, and/or biopsy proven liver cirrhosis of any cause
3. Informed consent
4. Abstinence from alcohol for > 2 weeks at the time of screening for inclusion
1. Pugh score > 10
2. Clinical evidence of active infection
3. Antibiotic treatment within 7 days prior to enrolment
4. Gastrointestinal haemorrhage within previous 2 weeks
5. Use of immunomodulating agents within previous month (steroids etc)
6. Use of proton pump inhibitors for preceding two weeks
7. Concomitant use of supplements (pre-, pro-, or synbiotics) likely to influence the study
8. Renal failure (such as hepatorenal syndrome), creatinine >150 mmol/l
9. Hepatic encephalopathy II to IV
10. Pancreatitis
11. Other organ failure
12. Hepatic or extra-hepatic malignancy
13. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Neutrophil function assessed using phagoburst and phagotest at day 0, months 1, 6 and 12 <br>2. Incidence of significant infection documented at time of clinical assessments at day 0, day 14, months 1, 3, 6, 9, 12
- Secondary Outcome Measures
Name Time Method 1. Gut barrier function assessed using lactulose/rhamnose/xylose intestinal permeability assay at day 0, months 1, 6<br>2. Inflammatory, cellular and humoral response assessed using luminex at day 0, months 1,6,12<br>3. Quality of life assessed using SF-36 at days 0, 14, months 1, 3, 6, 9, 12