Metabolic SyndromeNCT01182844
Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
A study testing Lactobacillus casei Shirota in people with Metabolic Syndrome, run by Vanessa Stadlbauer-Koellner, MD at 1 site in Austria.
Trial summary
Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an important role in the development of inflammation and metabolic syndrome in obesity. Modulation of gut flora by probiotics has been shown in animal studies to positively influence inflammation and metabolic disturbances. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Lactobacillus casei Shirota
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18
- Informed consent
- Fasting blood glucose >95mg/dL
- Metabolic syndrome defined by the National Cholesterol Education Program (NCEP) Adult Treatment Panel-III (ATP-III) -ATPIII criteria (3 out of 5)
- Abdominal obesity (waist circumference >102 in men or >88 in women)
- Elevated blood pressure (>135/>85) or drug treatment for elevated blood pressure
Show all 10Show fewer
- Fasting blood glucose >100mg/dL or previously known type 2 diabetes mellitus,
- High Density Lipoprotein (HDL) cholesterol <40 mg/dL (men) or <50 mg/dL (women) or drug treatment for low HDL cholesterol
- Triglycerides >150 mg/dL or drug treatment for elevated for high triglycerides
- HbA1C ≤7.0%
Who cannot join
- Drug treatment for diabetes mellitus
- Liver cirrhosis (biopsy proven) or elevated transaminases (>2x Upper Limit of Normla (ULN))
- Inflammatory bowel disease (Crohns disease, ulcerative colitis)
- Celiac disease
- Alcohol abuse (more than 40g alcohol per day in the history)
- Clinical evidence of active infection
Show all 12Show fewer
- Antibiotic treatment within 7 days prior to enrolment
- Use of immunomodulating agents within previous month (steroids etc.)
- Concomitant use of supplements (pre-, pro-, or synbiotics) likely to influence the study
- Any severe illness unrelated to metabolic syndrome
- Malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Internal Medicine, Medical University of Graz
Graz, 8036
About this study
Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an important role in the development of inflammation and metabolic syndrome in obesity. Modulation of gut flora by probiotics has been shown in animal studies to positively influence inflammation and metabolic disturbances.
Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora composition and gut permeability which leads to an improvement in neutrophil function and insulin resistance in obesity.
Read more
The aim of the current study is to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR expression) in patients with metabolic syndrome.
Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut flora composition, gut permeability, and endotoxemia in metabolic syndrome
Read the detailed description
Obesity and metabolic disorders (type 2 diabetes and insulin resistance) are tightly linked to inflammation. Obesity, a pandemic affecting 30-50% of the adult population, is mediated by a variety of genetic and environmental factors. It is well described that cytokines cause insulin resistance which causes hyperinsulinemia and excessive fat storage in adipose tissue and the liver. However, the triggering factor, linking inflammation to metabolic syndrome has not been fully elucidated yet.
Recently it has been hypothesized that the gut flora is an important factor in this vicious cycle of obesity, metabolic disease and inflammation. Firstly, metabolic activities of the gut microbiota facilitates the extraction of calories from ingested dietary substances and helps to store these calories in host adipose tissue for later use. Second, the gut bacterial flora of obese mice and humans include fewer Bacteroidetes and correspondingly more Firmicutes than that of their lean counterparts, suggesting that differences in caloric extraction of ingested food substances may be due to the composition of the gut microbiota. Furthermore, bacterial lipopolysaccharide derived from the intestinal microbiota may trigger inflammation, linking it to high-fat diet-induced metabolic syndrome. High-fat diet induces insulin resistance and oxidative stress in mice and is associated with increased gut permeability. high fat diet induces a low-grade endotoxemia in mice ("metabolic endotoxemia) and infusing endotoxin causes weight gain and insulin resistance. This has also been shown in humans, where patients with fatty liver had a susceptibility to higher gut permeability, possibly causing increased endotoxin levels.
Endotoxin and Lipopolysaccharide-binding protein (LBP) is elevated in obese patients, patients with type 2 diabetes and patients with liver steatosis. Endotoxin causes a significant increase in proinflammatory cytokine production in adipocytes via a TLR mediated pathway, contribution to the proinflammatory state in obesity. Endotoxin levels correlate with adiponectin and insulin suggesting a pathophysiological link between obesity, inflammation and metabolic disease.
As described above, endotoxin is related to increased inflammation and oxidative stress, causing insulin resistance. Adipocytes have been shown to play a dynamic role in regulation of inflammation by producing cytokines via a Toll-like receptor (TLR)/Nuclear Factor kappa B (NFkB) mediated pathway.But not only adipocytes are in a proinflammatory state - also circulating mononuclear cells have been described to be activated. Clinical evidence suggests immune dysfunction in obesity, since obese patients are more prone to infections after surgery, higher incidence of lower respiratory infection which is also underlined by impairment of cell-mediated immune responses in vivo and in vitro and a reduced intracellular killing by neutrophils.
A similar situation has been recently described in alcoholic cirrhosis and alcoholic hepatitis, which is also a proinflammatory condition with impaired innate immunity, leading to infection. Endotoxin has been described as a key mediator and inadequate activation of neutrophils leading to high oxidative burst and energy depletion of the cells with consecutive impaired phagocytic capacity has been described.
The most effective therapy of obesity - weight loss - leads to significant improvement of mononuclear cell activation. However, there is no data available on the effect of weight loss on gut flora, gut permeability and endotoxin.
Since weight loss is usually very hard to achieve, other therapeutic strategies have been tested. Since gut flora seems to be crucial in the development of the vicious cycle of obesity, inflammation and metabolic disease, several studies tried to modify the composition of gut microbiota. In mice treatment with antibiotics improved glucose tolerance by altering expression of genes involved in inflammation and metabolism. A similar result was found in mice treated with a probiotic that increases the number of Bifidobacterium spp., which leads to improved glucose tolerance, insulin secretion and a decrease in inflammatory tone. Finally treatment of mice with a probiotic decreased hepatic insulin resistance via a C-Jun N-terminal Kinase (JNK) and NFkB pathway, supporting the concept that intestinal bacteria induce endogenous signals that play a pathogenic role in hepatic insulin resistance.
Among the vast amount of bacteria described to alter gut flora and exert positive effects on the host, we have chosen to study Lactobacillus casei Shirota several reasons: Firstly this commercially available preparation delivers a high bacterial number in a relatively small volume and is available as a palatable milk drink. Furthermore Lactobacillus casei Shirota has been proven to survive the passage through the stomach and is present in the lower intestinal tract. It has also been shown that this bacterial strain can increases the amount of Lactobacilli and decreases the number of gram-negative organisms in the bacterial flora. This bacterial strain has been shown to be effective in modulating natural killer cell function and neutrophil function.
We hypothesize that Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora composition and gut permeability which leads to an improvement in neutrophil function and insulin resistance in obesity
Specific Aims:
- To investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR expression) in patients with metabolic syndrome.
- To investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut flora composition, gut permeability, and endotoxemia in metabolic syndrome
Plan of investigations:
Patients:
30 Patients with metabolic syndrome and increased gut permeability will be randomized to either receive food supplementation with a milk drink containing Lactobacillus casei Shirota (3 bottles a day, 65 ml each, containing Lactobacillus casei Shirota at a concentration of 10^8 colony forming units/ml) for twelve weeks or standard medical therapy.
- Conditions
- Metabolic Syndrome
- Being tested
- Lactobacillus casei Shirota
- Keywords
- metabolic syndrome, probiotic
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei ShirotaDietary supplement
Also called Yakult
3 bottles of Yakult(R) light per day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Lactobacillus casei Shirota | Experimental | 3 bottles of Yakult(R) light per day Receives: Dietary Supplement: Lactobacillus casei Shirota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Neutrophil Phagocytosis From Baseline to 3 Months
The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using Fluorescein isothiocyanate (FITC)-labelled opsonized E. coli bacteria.
Measured: 3 months
Change of Burst (%) From Baseline to 3 Months
The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using FITC-labelled opsonized E. coli bacteria.
The Phagoburst® kit (Orpegen Pharma, Heidelberg, Germany) is used to determine the percentage of neutrophils that produce reactive oxidants with or without stimulation.
Measured: 3 months
Secondary outcomes (5)
Change in Indices of Glucose Tolerance and Insulin Resistance
change in indices of glucose tolerance and insulin resistance (frequently sampled in an oral glucose tolerance test) at baseline and after 3 months Homeostasis model assessment (HOMA)- Insulin Resistance (IR): HOMA is calculated by [fasting glucose*fasting insulin/22.5] insulin (U/L), glucose (mmol/l) - higher values indicating more severe insulin resistance Quantitativer Insulin Sensitivitäts-Check Index (QUCIKI): QUICKI is calculated by [1/log (insulin0)+log(glucose0)] insulin (mU/L), glucose (mg/dL) - lower values indicating a improvement of insulin sensitivity Insulin Sensitivity Index (ISI): 0.222-00333*BMI - 0.0000779*Ins120 -0.0004222*age insulin (mU/L) lower values indicating a improvement of insulin sensitivity
Measured: 3 months
Change of Gut Permeability From Baseline to 3 Months
Change of gut permeability (lactulose/mannitol-test) from Baseline to 3 months
Measured: 3 months
Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months
Measured: 3 months
Change in Interleukin-6 (IL-6) From Baseline to 3 Months
Measured: 3 months
Change in Interleukin-10 (IL-10) From Baseline to 3 Months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanessa Stadlbauer-Koellner, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vanessa Stadlbauer-Koellner, MD, Medical University of Graz
- Investigators
- Vanessa Stadlbauer-Köllner, MD, Principal investigator, Dept. of Internal Medicine, Medical University of Graz, AustriaHarald Sourij, MD, Principal investigator, Dept. of Internal Medicine, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182844
- Sponsor's protocol ID
- vs09.2008
- Status last verified
- Sep 2020
- First submitted
- 13 Aug 2010
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stadlbauer V, Leber B, Lemesch S, Trajanoski S, Bashir M, Horvath A, Tawdrous M, Stojakovic T, Fauler G, Fickert P, Hogenauer C, Klymiuk I, Stiegler P, Lamprecht M, Pieber TR, Tripolt NJ, Sourij H. Lactobacillus casei Shirota Supplementation Does Not Restore Gut Microbiota Composition and Gut Barrier in Metabolic Syndrome: A Randomized Pilot Study. PLoS One. 2015 Oct 28;10(10):e0141399. doi: 10.1371/journal.pone.0141399. eCollection 2015.
PubMed 26509793Leber B, Tripolt NJ, Blattl D, Eder M, Wascher TC, Pieber TR, Stauber R, Sourij H, Oettl K, Stadlbauer V. The influence of probiotic supplementation on gut permeability in patients with metabolic syndrome: an open label, randomized pilot study. Eur J Clin Nutr. 2012 Oct;66(10):1110-5. doi: 10.1038/ejcn.2012.103. Epub 2012 Aug 8.
PubMed 22872030
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
- ClinicalTrials.gov ID
- NCT01182844
- Acronym / sponsor ID
- vs09.2008
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanessa Stadlbauer-Koellner, MDUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an important role in the development of inflammation and metabolic syndrome in obesity. Modulation of gut flora by probiotics has been shown in animal studies to positively influence inflammation and metabolic disturbances.
Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora composition and gut permeability which leads to an improvement in neutrophil function and insulin resistance in obesity.
The aim of the current study is to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR expression) in patients with metabolic syndrome.
Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut flora composition, gut permeability, and endotoxemia in metabolic syndrome
Detailed description
Obesity and metabolic disorders (type 2 diabetes and insulin resistance) are tightly linked to inflammation. Obesity, a pandemic affecting 30-50% of the adult population, is mediated by a variety of genetic and environmental factors. It is well described that cytokines cause insulin resistance which causes hyperinsulinemia and excessive fat storage in adipose tissue and the liver. However, the triggering factor, linking inflammation to metabolic syndrome has not been fully elucidated yet.
Recently it has been hypothesized that the gut flora is an important factor in this vicious cycle of obesity, metabolic disease and inflammation. Firstly, metabolic activities of the gut microbiota facilitates the extraction of calories from ingested dietary substances and helps to store these calories in host adipose tissue for later use. Second, the gut bacterial flora of obese mice and humans include fewer Bacteroidetes and correspondingly more Firmicutes than that of their lean counterparts, suggesting that differences in caloric extraction of ingested food substances may be due to the composition of the gut microbiota. Furthermore, bacterial lipopolysaccharide derived from the intestinal microbiota may trigger inflammation, linking it to high-fat diet-induced metabolic syndrome. High-fat diet induces insulin resistance and oxidative stress in mice and is associated with increased gut permeability. high fat diet induces a low-grade endotoxemia in mice ("metabolic endotoxemia) and infusing endotoxin causes weight gain and insulin resistance. This has also been shown in humans, where patients with fatty liver had a susceptibility to higher gut permeability, possibly causing increased endotoxin levels.
Endotoxin and Lipopolysaccharide-binding protein (LBP) is elevated in obese patients, patients with type 2 diabetes and patients with liver steatosis. Endotoxin causes a significant increase in proinflammatory cytokine production in adipocytes via a TLR mediated pathway, contribution to the proinflammatory state in obesity. Endotoxin levels correlate with adiponectin and insulin suggesting a pathophysiological link between obesity, inflammation and metabolic disease.
As described above, endotoxin is related to increased inflammation and oxidative stress, causing insulin resistance. Adipocytes have been shown to play a dynamic role in regulation of inflammation by producing cytokines via a Toll-like receptor (TLR)/Nuclear Factor kappa B (NFkB) mediated pathway.But not only adipocytes are in a proinflammatory state - also circulating mononuclear cells have been described to be activated. Clinical evidence suggests immune dysfunction in obesity, since obese patients are more prone to infections after surgery, higher incidence of lower respiratory infection which is also underlined by impairment of cell-mediated immune responses in vivo and in vitro and a reduced intracellular killing by neutrophils.
A similar situation has been recently described in alcoholic cirrhosis and alcoholic hepatitis, which is also a proinflammatory condition with impaired innate immunity, leading to infection. Endotoxin has been described as a key mediator and inadequate activation of neutrophils leading to high oxidative burst and energy depletion of the cells with consecutive impaired phagocytic capacity has been described.
The most effective therapy of obesity - weight loss - leads to significant improvement of mononuclear cell activation. However, there is no data available on the effect of weight loss on gut flora, gut permeability and endotoxin.
Since weight loss is usually very hard to achieve, other therapeutic strategies have been tested. Since gut flora seems to be crucial in the development of the vicious cycle of obesity, inflammation and metabolic disease, several studies tried to modify the composition of gut microbiota. In mice treatment with antibiotics improved glucose tolerance by altering expression of genes involved in inflammation and metabolism. A similar result was found in mice treated with a probiotic that increases the number of Bifidobacterium spp., which leads to improved glucose tolerance, insulin secretion and a decrease in inflammatory tone. Finally treatment of mice with a probiotic decreased hepatic insulin resistance via a C-Jun N-terminal Kinase (JNK) and NFkB pathway, supporting the concept that intestinal bacteria induce endogenous signals that play a pathogenic role in hepatic insulin resistance.
Among the vast amount of bacteria described to alter gut flora and exert positive effects on the host, we have chosen to study Lactobacillus casei Shirota several reasons: Firstly this commercially available preparation delivers a high bacterial number in a relatively small volume and is available as a palatable milk drink. Furthermore Lactobacillus casei Shirota has been proven to survive the passage through the stomach and is present in the lower intestinal tract. It has also been shown that this bacterial strain can increases the amount of Lactobacilli and decreases the number of gram-negative organisms in the bacterial flora. This bacterial strain has been shown to be effective in modulating natural killer cell function and neutrophil function.
We hypothesize that Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora composition and gut permeability which leads to an improvement in neutrophil function and insulin resistance in obesity
Specific Aims:
- To investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR expression) in patients with metabolic syndrome.
- To investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut flora composition, gut permeability, and endotoxemia in metabolic syndrome
Plan of investigations:
Patients:
30 Patients with metabolic syndrome and increased gut permeability will be randomized to either receive food supplementation with a milk drink containing Lactobacillus casei Shirota (3 bottles a day, 65 ml each, containing Lactobacillus casei Shirota at a concentration of 10^8 colony forming units/ml) for twelve weeks or standard medical therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Lactobacillus casei Shirota | Experimental | Dietary Supplement: Lactobacillus casei Shirota3 bottles of Yakult(R) light per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18
- Informed consent
- Fasting blood glucose >95mg/dL
- Metabolic syndrome defined by the National Cholesterol Education Program (NCEP) Adult Treatment Panel-III (ATP-III) -ATPIII criteria (3 out of 5)
- HbA1C ≤7.0%
Key exclusion criteria (12 listed)
- Drug treatment for diabetes mellitus
- Liver cirrhosis (biopsy proven) or elevated transaminases (>2x Upper Limit of Normla (ULN))
- Inflammatory bowel disease (Crohns disease, ulcerative colitis)
- Celiac disease
- Alcohol abuse (more than 40g alcohol per day in the history)
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 |
|---|---|---|
| Lactobacillus casei ShirotaAlso: Yakult3 bottles of Yakult(R) light per day | Dietary supplement | Lactobacillus casei Shirota |
Primary outcome
Change of Neutrophil Phagocytosis From Baseline to 3 Months
Time frame: 3 months
The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using Fluorescein isothiocyanate (FITC)-labelled opsonized E. coli bacteria.
Change of Burst (%) From Baseline to 3 Months
Time frame: 3 months
The Phagotest® (Orpegen Pharma, Heidelberg, Germany) is used to measure phagocytosis by using FITC-labelled opsonized E. coli bacteria. The Phagoburst® kit (Orpegen Pharma, Heidelberg, Germany) is used to determine the percentage of neutrophils that produce reactive oxidants with or without stimulation.
5 secondary outcomes
Change in Indices of Glucose Tolerance and Insulin Resistance
Time frame: 3 months
Change of Gut Permeability From Baseline to 3 Months
Time frame: 3 months
Change in oxLDL (Oxidative Low Density Lipoprotein) From Baseline to 3 Months
Time frame: 3 months
Change in Interleukin-6 (IL-6) From Baseline to 3 Months
Time frame: 3 months
Change in Interleukin-10 (IL-10) From Baseline to 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26509793Stadlbauer V, Leber B, Lemesch S, Trajanoski S, Bashir M, Horvath A, Tawdrous M, Stojakovic T, Fauler G, Fickert P, Hogenauer C, Klymiuk I, Stiegler P, Lamprecht M, Pieber TR, Tripolt NJ, Sourij H. Lactobacillus casei Shirota Supplementation Does Not Restore Gut Microbiota Composition and Gut Barrier in Metabolic Syndrome: A Randomized Pilot Study. PLoS One. 2015 Oct 28;10(10):e0141399. doi: 10.1371/journal.pone.0141399. eCollection 2015.
- Derived from this study: PubMed 22872030Leber B, Tripolt NJ, Blattl D, Eder M, Wascher TC, Pieber TR, Stauber R, Sourij H, Oettl K, Stadlbauer V. The influence of probiotic supplementation on gut permeability in patients with metabolic syndrome: an open label, randomized pilot study. Eur J Clin Nutr. 2012 Oct;66(10):1110-5. doi: 10.1038/ejcn.2012.103. Epub 2012 Aug 8.
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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.
Vanessa Stadlbauer-Köllner, MD principal investigator
Dept. of Internal Medicine, Medical University of Graz, Austria
Harald Sourij, MD principal investigator
Dept. of Internal Medicine, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei Shirota in people with Metabolic Syndrome, run by Vanessa Stadlbauer-Koellner, MD 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 10 inclusion and 12 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 29 Sep 2020. 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. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Neutrophil Phagocytosis From Baseline to 3 Months (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT01182844, which also lists 2 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 29 Sep 2020.