Cirrhosis Digestive System
Conditions
Interventions
92 patients will be randomised into two groups:
Group 1: Oral Yakult yoghurt 3 bottles a day (65 ml each, containing Lactobacillus casei Shirota at a concentration of 108/ml)
Group 2: Similar looking
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Neutrophil function assessed using phagoburst and phagotest at day 0, months 1, 6 and 12 2. Incidence of significant infection documented at time of clinical assessments at day 0, day 14, months 1, 3, 6, 9, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gut barrier function assessed using lactulose/rhamnose/xylose intestinal permeability assay at day 0, months 1, 6 2. Inflammatory, cellular and humoral response assessed using luminex at day 0, months 1,6,12 3. Quality of life assessed using SF-36 at days 0, 14, months 1, 3, 6, 9, 12 | — |
Countries
England, United Kingdom
Outcome results
None listed