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Liver CirrhosisPICNCT01607528

Influence of Probiotics on Infections in Cirrhosis

A study testing Winclove-849 in people with Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Liver cirrhosis is the 10th most common cause of death in the western world. Infection is the most common precipitant of deterioration of liver function in cirrhosis. Endotoxin, derived from gram-negative organisms in the gut, can enter the circulation due to increased gut permeability and contributes to neutrophil… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis
What is being tested?
Winclove-849
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteAustria
Study dates
Jul 2012to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical and radiological evidence of cirrhosis, and/or biopsy proven liver cirrhosis of any cause
  • Informed consent

Who cannot join

  • 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.)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of Internal Medicine, Medical University of Geraz

    Graz, 8036

Other trials in Austria

About this study

Official title: Probiotic Modulation of Gut Microflora in Cirrhosis: Influence on Immune Function and Infections

Liver cirrhosis is the 10th most common cause of death in the western world. Infection is the most common precipitant of deterioration of liver function in cirrhosis. Endotoxin, derived from gram-negative organisms in the gut, can enter the circulation due to increased gut permeability and contributes to neutrophil dysfunction, infection risk and mortality in alcoholic cirrhotics. As probiotics decrease gram-negative organisms in the gut and/or decrease gut permeability, the investigators hypothesize that probiotic treatment would restore neutrophil function and prevent infection in alcoholic cirrhosis.

The investigators hypothesize that administration of a probiotic mixture in patients with liver cirrhosis will improve innate immune function through alteration of the gut bacterial flora and gut barrier integrity.

Read more

The aim of this randomised, double-blinded placebo-controlled study is to assess whether food supplementation with probiotic mixture improves neutrophil phagocytic capacity in patients with cirrhosis and decreases the incidence of significant infections.

92 patients with alcoholic cirrhosis will be included according to a sample size calculation from preliminary data. Patients will be randomized in two groups: Group 1 receives a probiotic mixture Group 2 receives a similar looking and tasting placebo without bacteria. The recruited patients will be treated for 6 months. Besides routine clinical and laboratory assessments, neutrophil function, toll-like receptor expression, endotoxin levels, bacterial DNA, cytokine levels, albumin oxidation, gut permeability and analysis of gut microflora will be performed. Furthermore nutritional status and quality of life will be assessed.

Primary endpoints will be neutrophil phagocytosis. Secondary endpoints will be significant infection, neutrophil oxidative burst, neutrophil toll-like receptor expression, endotoxin levels, bacterial DNA; cytokine levels, albumin oxidation, gut barrier function and bacterial flora, nutritional status and quality of life.

If our hypothesis holds true, probiotics will provide an easily applicable and cost effective method to improve immune function and to prevent infection in liver cirrhosis. It is possible that this can improve survival of patients with liver cirrhosis.

Conditions
Liver Cirrhosis
Being tested
Winclove-849, Placebo
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Winclove-849Dietary supplement

    6 g of Winclove-849 containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g

  • PlaceboDietary supplement

    A similar looking and tasting powder with no active substances

Study groups in NCT01607528
Study groupRoleWhat they receive
ProbioticActive comparator6 g of Winclove-849 containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 10E9 cfu/g per day
Receives: Dietary Supplement: Winclove-849
PlaceboPlacebo comparatorA similar looking and tasting powder
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in neutrophil phagocytic capacity

    Percentage of neutrophil granulocytes showing phagocytosis of FITC (fluorescein isothiocyanate) -labelled E.coli bacteria

    Measured: Change from baseline to 6 months

Secondary outcomes (10)

  1. Number of clinically significant infections

    Occurence of infections that require specific treatment and/or hospitalisation during the study period of 12 months

    Measured: during 12 months

  2. endotoxin levels

    Endotoxin in serum (EU/ml)

    Measured: 0, 6, 12 months

  3. neutrophil oxidative burst

    percentage of neutrophil granulocytes showing oxidative burst with and without stimulation and mean fluorescence activity

    Measured: 0, 6, 12 months

  4. neutrophil toll like receptor expression

    percentage of neutrophil granulocytes showing TLR (Toll-like receptor) 2, TLR4 or TLR9 expression and mean fluorescence activity

    Measured: 0, 6, 12 months

  5. albumin oxidation

    oxidative status of albumin in the plasma (percentage of (human mercaptalbumin) HMA, (human non-mercaptalbumin) HNA1 and HNA2)

    Measured: 0, 6, 12 months

  6. inflammatory response

    elevation of one or more inflammatory markers: C reactive protein (mg/ml), lipopolysaccharide binding protein (ng/ml), soluble CD (cluster of differentiation) 14 (ng/ml)

    Measured: 0, 6, 12 months

  7. bacterial flora

    isolation of bacterial DNA and sequencing the gut microbiome from stool and duodenal aspirate

    Measured: 0, 6, 12 months

  8. quality of life

    (short form) SF-36 questionaire

    Measured: 0, 6, 12 months

  9. nutritional status

    subjective global assessment

    Measured: 0,6, 12 months

  10. changes in gut permeability over time

    elevated lactulose mannitol ratio, elevated zonulin

    Measured: 0, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMar 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01607528
Sponsor's protocol ID
PIC-2010
Acronym
PIC
Status last verified
May 2016
First submitted
13 Apr 2012
Last updated
5 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Haller R, Feldbacher N, Furst S, Woltsche J, Gulden L, Schwarzl J, Traub J, Madl T, Habisch H, Horvath A, Stadlbauer V. Clinical and Mechanistic Association Between Intestinal Permeability and the Gut Microbiome in Cirrhosis: Role of Phascolarctobacterium. United European Gastroenterol J. 2026 Jul;14(6):e70262. doi: 10.1002/ueg2.70262.

    PubMed 42438428

  • Egger M, Horvath A, Pruller F, Fickert P, Finkelman M, Kriegl L, Gronbaek H, Moller HJ, Prattes J, Krause R, Hoenigl M, Stadlbauer V. Fungal translocation measured by serum 1,3-ss-D-glucan correlates with severity and outcome of liver cirrhosis-A pilot study. Liver Int. 2023 Sep;43(9):1975-1983. doi: 10.1111/liv.15648. Epub 2023 Jun 19.

    PubMed 37334864

  • Stadlbauer V, Komarova I, Klymiuk I, Durdevic M, Reisinger A, Blesl A, Rainer F, Horvath A. Disease severity and proton pump inhibitor use impact strongest on faecal microbiome composition in liver cirrhosis. Liver Int. 2020 Apr;40(4):866-877. doi: 10.1111/liv.14382. Epub 2020 Jan 24.

    PubMed 31943691

Questions about this trial

What is this clinical trial studying?

A study testing Winclove-849 in people with Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in neutrophil phagocytic capacity (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01607528, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.

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