Cirrhosis, LiverNCT03236090
Effect of Vivomixx® on Neuroinflammation in Patients Withs Cirrhosis
A study testing Vivomixx in people with Cirrhosis, Liver, 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 randomized placebo-controlled clinical trial Study Duration: 2 years Study Center: Single center Hospital de la Santa Creu i Sant Pau, Barcelona Objectives: To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in patients with cirrhosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Vivomixx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2017to 9 Mar 2018
- 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
- Outpatients with cirrhosis and refractory ascites according to current definition (29) (substudy 1), and hospitalized patients with cirrhosis and an episode of bacterial infection (substudy 2) 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 (28). Bacteremia, urinary infections, pneumonia, cellulitis, other bacterial infections and possible or suspected infections will be diagnosed according to current guidelines (13,14,28). All patients with SBP, bacteremia or pneumonia will be included. However patients with urinary infections, cellulitis or suspected infection these non-SBP infections will be required to fulfil the following requirements: at least two criteria of SIRS (systemic inflammatory response syndrome) (Annex I) (30) and CRP (C-reactive protein) >= 10 mg/dl (28).
Who cannot join
- Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy determining a poor short-term prognosis.
- Advanced liver insufficiency [MELD (model for end-stage liver disease) >25].
- Marked symptomatic comorbidities (neurological, cardiac, pulmonary, renal, psychiatric, HIV infection).
- Septic shock, ileus, need for tracheal intubation or intensive care unit.
- Immunomodulatory drugs.
- In substudy 1, any infection at inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Vivomixx® on Neuroinflammation Ans Systemic Inflammatory Response in Patients With Cirrhosis
Study Design:
Double-blind randomized placebo-controlled clinical trial
Study Duration:
2 years
Study Center:
Single center Hospital de la Santa Creu i Sant Pau, Barcelona
Objectives:
To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in patients with cirrhosis
Read the detailed description
Study variables Main variables
- Neuroinflammation
- Systemic inflammatory response Secondary variables
- Cognitive function
- Bacterial translocation
- Intestinal barrier
- Systemic oxidative damage
- Time until SBP or other bacterial infection resolution in patients with infections
- Incidence of complications of cirrhosis and mortality during the study 40 patients, 20 and 30 in each of the two substudies, respectively Diagnosis and Main Inclusion Criteria
- Decompensated patients with cirrhosis:
- Outpatients with refractory ascites (substudy 1) (n=20)
- Patients hospitalized because bacterial infection (substudy 2) (n=30)
Study Product:
Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
Duration of administration:
30 days Follow up The following patients' assessments will be performed: in substudy 1 at baseline and at the end of the treatment (30 days), and in substudy 2 at baseline, on day 1, day 2, day 3, day 7, at infection resolution, and at discharge or day 30.
Clinical and analytical assessments will be performed every three months after the end of the study Comparator Placebo (we evaluate the probiotic Vivomixx® vs placebo as adjunctive in addition to the standard of care) Statistical Methodology Fisher's exact test for categorical variables and Student's "t" test and Mann-Whitney and Wilcoxon tests for quantitative variables. Correlations will be assessed by Spearman test. A two-sided p value <0.05 will be considered statistically significant
- Conditions
- Cirrhosis, Liver
- Being tested
- Vivomixx
- Keywords
- Cirrhosis, Probiotics, Systemic inflammation, neuroinflammation, Cognitive function, Bacterial translocation
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivomixxDietary supplement
Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
| Study group | Role | What they receive |
|---|---|---|
| Outpatients with refractory ascites | Active comparator | 20 consecutive outpatients with cirrhosis and refractory ascites Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25) Receives: Dietary Supplement: Vivomixx |
| Patients hospitalized because bacterial infection | Active comparator | 30 consecutive patients with cirrhosis and bacterial infections. All patients will receive endovenous antibiotics and, only in the case of patients with SBP, also intravenous albumin Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25) Receives: Dietary Supplement: Vivomixx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuroinflammation
For substudy 1, neuroinflammation will be measured by MRI at baseline and 30 days
Measured: Change from baseline at 30 days
Change in neuroinflammation
For substudy 2, neuroinflammation will be measured by MRI at baseline and 3 days
Measured: Change from baseline at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start15 Jul 2017
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Why it stopped: Problems to recruit patients due to exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Decompensated patients with cirrhosis: 1. Outpatients with refractory ascites (substudy 1) (n=20) 2. Patients hospitalized because bacterial infection (substudy 2) (n=30)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236090
- Sponsor's protocol ID
- IIBSP-VIV-2016-109
- Status last verified
- Mar 2018
- First submitted
- 29 Jun 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Vivomixx® on Neuroinflammation Ans Systemic Inflammatory Response in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT03236090
- Acronym / sponsor ID
- IIBSP-VIV-2016-109
- Conditions
- Cirrhosis, Liver
- Keywords
- Cirrhosis, Probiotics, Systemic inflammation, neuroinflammation, Cognitive function, Bacterial translocation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems to recruit patients due to exclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 1 Aug 2017 (actual)
- 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 randomized placebo-controlled clinical trial
Study Duration:
2 years
Study Center:
Single center Hospital de la Santa Creu i Sant Pau, Barcelona
Objectives:
To assess the effect of Vivomixx® on neuroinflammation and systemic inflammatory response in patients with cirrhosis
Detailed description
Study variables Main variables
- Neuroinflammation
- Systemic inflammatory response Secondary variables
- Cognitive function
- Bacterial translocation
- Intestinal barrier
- Systemic oxidative damage
- Time until SBP or other bacterial infection resolution in patients with infections
- Incidence of complications of cirrhosis and mortality during the study 40 patients, 20 and 30 in each of the two substudies, respectively Diagnosis and Main Inclusion Criteria
- Decompensated patients with cirrhosis:
- Outpatients with refractory ascites (substudy 1) (n=20)
- Patients hospitalized because bacterial infection (substudy 2) (n=30)
Study Product:
Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
Duration of administration:
30 days Follow up The following patients' assessments will be performed: in substudy 1 at baseline and at the end of the treatment (30 days), and in substudy 2 at baseline, on day 1, day 2, day 3, day 7, at infection resolution, and at discharge or day 30.
Clinical and analytical assessments will be performed every three months after the end of the study Comparator Placebo (we evaluate the probiotic Vivomixx® vs placebo as adjunctive in addition to the standard of care) Statistical Methodology Fisher's exact test for categorical variables and Student's "t" test and Mann-Whitney and Wilcoxon tests for quantitative variables. Correlations will be assessed by Spearman test. A two-sided p value <0.05 will be considered statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Decompensated patients with cirrhosis: 1. Outpatients with refractory ascites (substudy 1) (n=20) 2. Patients hospitalized because bacterial infection (substudy 2) (n=30)
| Arm | Type | Receives |
|---|---|---|
| Outpatients with refractory ascites | Active comparator | Dietary Supplement: Vivomixx20 consecutive outpatients with cirrhosis and refractory ascites Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25) |
| Patients hospitalized because bacterial infection | Active comparator | Dietary Supplement: Vivomixx30 consecutive patients with cirrhosis and bacterial infections. All patients will receive endovenous antibiotics and, only in the case of patients with SBP, also intravenous albumin Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients with cirrhosis and refractory ascites according to current definition (29) (substudy 1), and hospitalized patients with cirrhosis and an episode of bacterial infection (substudy 2) 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 (28). Bacteremia, urinary infections, pneumonia, cellulitis, other bacterial infections and possible or suspected infections will be diagnosed according to current guidelines (13,14,28). All patients with SBP, bacteremia or pneumonia will be included. However patients with urinary infections, cellulitis or suspected infection these non-SBP infections will be required to fulfil the following requirements: at least two criteria of SIRS (systemic inflammatory response syndrome) (Annex I) (30) and CRP (C-reactive protein) >= 10 mg/dl (28).
Key exclusion criteria (6 listed)
- Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy determining a poor short-term prognosis.
- Advanced liver insufficiency [MELD (model for end-stage liver disease) >25].
- Marked symptomatic comorbidities (neurological, cardiac, pulmonary, renal, psychiatric, HIV infection).
- Septic shock, ileus, need for tracheal intubation or intensive care unit.
- Immunomodulatory drugs.
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 |
|---|---|---|
| VivomixxVivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25) | Dietary supplement | Outpatients with refractory ascites, Patients hospitalized because bacterial infection |
Primary outcome
Change in neuroinflammation
Time frame: Change from baseline at 30 days
For substudy 1, neuroinflammation will be measured by MRI at baseline and 30 days
Change in neuroinflammation
Time frame: Change from baseline at 3 days
For substudy 2, neuroinflammation will be measured by MRI at baseline and 3 days
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 13 Mar 2018.
- Individual participant dataSharing planned: No
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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 study testing Vivomixx in people with Cirrhosis, Liver, 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 6 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 13 Mar 2018. 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. 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 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?
Change in neuroinflammation (time frame: Change from baseline at 30 days). The study lists 2 primary outcomes in all. 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 13 Mar 2018.