Spontaneous Bacterial PeritonitisPhase 3NCT02552862
Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
A Phase 3 study testing Vivomixx® in people with Spontaneous Bacterial Peritonitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Bacterial Peritonitis
- What is being tested?
- Vivomixx®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Dec 2018
- Phase
- Phase 3
- 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
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Adjunctive Vivomixx® in Addition to Antibiotics on Systemic and Cerebral Inflammatory Response in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
Study Design: Double-blind placebo-controlled clinical trial
Study Duration:2 years
Read more
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.
- Conditions
- Spontaneous Bacterial Peritonitis
- Being tested
- Vivomixx®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivomixx®Drug
Also called Vivomixx ®
Vivomixx® is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) and lactobacilli (L. paracasei DSM 24733, L. acidophilus DSM 24735, L. delbrueckii subsp bulgaricus DSM 24734, L. plantarum DSM 24730). The active agent will be supplied as a 4.4g sachet at a dose of 450 billion live bacteria per sachet with maltose and silicon dioxide as excipients.
PlaceboDrug
Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent.
| Study group | Role | What they receive |
|---|---|---|
| Vivomixx® | Active comparator | Vivomixx® is a probiotic mixture of 8 proprietary strains. Thirty consecutive patients with cirrhosis and SBP will be randomized to receive Vivomixx® , sachets containing 450 x 109 bacteria, 2 every 12 hours during all the hospitalization until a maximum of 30 days (n=15), or placebo (n=15).
All patients will receive endovenous antibiotics and also intravenous albumin 1.5 g/kg weight the first day and 1 g/kg weight the third day of treatment. The management of patients will follow current guidelines. Receives: Drug: Vivomixx® |
| Placebo | Placebo comparator | Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bacterial translocation (composite measure)
Bacterial translocation will be evaluated by change from baseline in bacterial DNA in blood and ascitic fluid, lipopolysaccharide binding protein (LBP), intestinal fatty acid-binding protein (I-FABP) and intestinal bile acid binding protein (I-BABP) in blood, and polyethylene glycols (PEG) and claudin 3 in urine .
Measured: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Secondary outcomes (3)
Changes in systemic inflammatory response and systemic oxidative damage (composite measure)
Systemic Inflammation and immune response will be evaluated by change from baseline in serum C reactive protein (CRP), interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α, IL-10, IL-12, IL-18, IL-22, sTNFR-1, sTNFR-2, sCD163, matrix metalloproteinase (MMP) -9, interferon (IFN)-γ, vascular endothelial growth factor (VEGF), claudin-5, nitrites and nitrates in serum and ascitic fluid.
Systemic oxidative damage will be evaluated by change from baseline in determination of malondialdehyde (MDA) in blood.
Measured: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Changes in cognitive function (composite measure)
Cognitive function will be evaluated by change from baseline in Trail-Making Test A (TMT-A), Trail-Making Test B (TMT-B), and Digit Symbol Test (DST).
Measured: At baseline at infection resolution (an expected average of 7 days)
Changes in brain inflammation (composite measure)
Brain inflammation will be evaluated by change from baseline in MRI and different biomarkers of neuroinflammation.
A designed MR protocol will be produced, including imaging using different sequences, and more biochemical (MR spectroscopy) and functional (DTI) studies.
Measured: At baseline (during the first 12-24 hours after inclusion in the study) and after 3 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: No candidates during recruiting time. There were no candidates meeting the inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552862
- Sponsor's protocol ID
- IIBSP-VSL-2014-49
- Status last verified
- Dec 2016
- First submitted
- 26 Aug 2015
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Adjunctive Vivomixx® in Addition to Antibiotics on Systemic and Cerebral Inflammatory Response in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)
- ClinicalTrials.gov ID
- NCT02552862
- Acronym / sponsor ID
- IIBSP-VSL-2014-49
- Conditions
- Spontaneous Bacterial Peritonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No candidates during recruiting time. There were no candidates meeting the inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivomixx® | Active comparator | Drug: Vivomixx®Vivomixx® is a probiotic mixture of 8 proprietary strains. Thirty consecutive patients with cirrhosis and SBP will be randomized to receive Vivomixx® , sachets containing 450 x 109 bacteria, 2 every 12 hours during all the hospitalization until a maximum of 30 days (n=15), or placebo (n=15). All patients will receive endovenous antibiotics and also intravenous albumin 1.5 g/kg weight the first day and 1 g/kg weight the third day of treatment. The management of patients will follow current guidelines. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivomixx®Also: Vivomixx ®Vivomixx® is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) and lactobacilli (L. paracasei DSM 24733, L. acidophilus DSM 24735, L. delbrueckii subsp bulgaricus DSM 24734, L. plantarum DSM 24730). The active agent will be supplied as a 4.4g sachet at a dose of 450 billion live bacteria per sachet with maltose and silicon dioxide as excipients. | Drug | Vivomixx® |
| PlaceboPlacebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent. | Drug | Placebo |
Primary outcome
Changes in bacterial translocation (composite measure)
Time frame: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Bacterial translocation will be evaluated by change from baseline in bacterial DNA in blood and ascitic fluid, lipopolysaccharide binding protein (LBP), intestinal fatty acid-binding protein (I-FABP) and intestinal bile acid binding protein (I-BABP) in blood, and polyethylene glycols (PEG) and claudin 3 in urine .
3 secondary outcomes
Changes in systemic inflammatory response and systemic oxidative damage (composite measure)
Time frame: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge
Changes in cognitive function (composite measure)
Time frame: At baseline at infection resolution (an expected average of 7 days)
Changes in brain inflammation (composite measure)
Time frame: At baseline (during the first 12-24 hours after inclusion in the study) and after 3 days of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vivomixx® in people with Spontaneous Bacterial Peritonitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 8 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: withdrawn, as of the sponsor's last update on 15 Dec 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changes in bacterial translocation (composite measure) (time frame: At baseline, daily until infection resolution (an expected average of 7 days) and at three months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2016.