Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial … (NCT02552862) | Clinical Trial Compass
WithdrawnPhase 3
Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
Stopped: No candidates during recruiting time. There were no candidates meeting the inclusion criteria
Spain0Started 2016-09
Plain-language summary
Study Design: Double-blind placebo-controlled clinical trial
Study Duration:2 years
Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)
Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in patients with cirrhosis and SBP
Number of Subjects: 30
Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau
Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2 every 12 hours during hospitalization (n=15), or placebo (n=15)
Duration of administration: During hospitalization due to SBP episode
Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could decrease bacterial translocation and systemic and cerebral proinflammatory state. This would result in a faster SBP resolution, a decrease in the incidence of complications and an improvement in cognitive function.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau.
Cirrhosis will be diagnosed by clinical, analytical and ultrasonographic findings or by liver biopsy. SBP will be diagnosed by an ascitic fluid neutrophil count \> 250/mm3 with or without positive culture .
Exclusion Criteria:
* Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy.
* Advanced liver insufficiency \[MELD (model for end-stage liver disease) \>25\].
* Active alcohol intake (in the previous 3 months).
* Neurological disease.
* Marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression, HIV infection).
* Previous antibiotic treatment, including norfloxacin and rifaximin.
* Septic shock, ileus, need for tracheal intubation or intensive care unit.
* Immunomodulatory drugs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in bacterial translocation (composite measure)
Timeframe: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Trial details
NCT IDNCT02552862
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau