Influence of Probiotics on Infections in Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT01607528
• Date of registration: 13/04/2012
• Prospective Registration: Yes
• Primary sponsor: Medical University of Graz
• Public title: Influence of Probiotics on Infections in Cirrhosis PIC
• Scientific title: Probiotic Modulation of Gut Microflora in Cirrhosis: Influence on Immune Function and Infections
• Date of first enrolment: July 2012
• Target sample size: 92
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01607528
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Vanessa Stadlbauer-Köllner, MD
• Affiliation: Medical University of Graz

Key inclusion & exclusion criteria

Inclusion Criteria: • Patients aged between 18-80 years

- Clinical and radiological evidence of cirrhosis, and/or biopsy proven liver cirrhosis
of any cause

- Informed consent

Exclusion Criteria:

- Child-Pugh score > 11

- Abstinence from alcohol for < 2 weeks at the time of screening for inclusion

- Clinical evidence of active infection

- Antibiotic treatment within 7 days prior to enrolment

- Gastrointestinal haemorrhage within previous 2 weeks

- Use of immunomodulating agents within previous month (steroids etc.)

- Use of proton pump inhibitors for preceding two weeks

- Concomitant use of supplements (pre-, pro-, or synbiotics) likely to influence the
study

- Renal failure (such as hepatorenal syndrome), creatinine >1.7 mg/dL

- Hepatic encephalopathy II to IV

- Pancreatitis

- Other organ failure

- Hepatic or extra-hepatic malignancy

- Pregnancy

- Presumed non-compliance to the study medication



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Cirrhosis

Intervention(s)

Dietary Supplement: Winclove-849

Dietary Supplement: Placebo

Primary Outcome(s)

Change in neutrophil phagocytic capacity [Time Frame: Change from baseline to 6 months]

Secondary Outcome(s)

endotoxin levels [Time Frame: 0, 6, 12 months]

albumin oxidation [Time Frame: 0, 6, 12 months]

Number of clinically significant infections [Time Frame: during 12 months]

neutrophil toll like receptor expression [Time Frame: 0, 6, 12 months]

bacterial flora [Time Frame: 0, 6, 12 months]

quality of life [Time Frame: 0, 6, 12 months]

neutrophil oxidative burst [Time Frame: 0, 6, 12 months]

nutritional status [Time Frame: 0,6, 12 months]

changes in gut permeability over time [Time Frame: 0, 6, 12 months]

inflammatory response [Time Frame: 0, 6, 12 months]

Secondary ID(s)

PIC-2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Austrian Science Fund (FWF)