HypercholesterolemiaPhase 2NCT01341613
Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation
A Phase 2 study testing Cardioviva™ supplement capsule in people with Hypercholesterolemia, run by Micropharma Limited at 1 site in Czechia.
Trial summary
Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Cardioviva™ supplement capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteCzechia
- Study dates
- May 2011to Oct 2011
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged 20 to 75 years (bounds included)
- LDL-Cholesterol above 3.4 mmol/L (<15% variation between visits V1 and V2-1)
- TG levels below 4.0 mmol/L (checked at visits V0 and V2-1)
- BMI range will be 22 to 32 kg/m²
- Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines)
- For subjects on statin monotherapy: dosage of statin must be stable for at least 3 months prior to the study beginning (15-20% of all subjects)
Show all 10Show fewer
- Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated
- Signed informed consent form prior to inclusion in the study
- Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study
- For female subjects: effective contraceptive methods used
Who cannot join
- Use of cholesterol lowering prescription drugs other than statin monotherapy within the last 6 months
- Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription food supplements within last 3 months
- History of chronic use of alcohol (>2 drinks/d)
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin
- Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months
- Diabetic subject (Type I or Type II)
Show all 13Show fewer
- Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
- History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
- Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives
- History of eating disorders
- Exercise greater than 15 miles/wk or 4,000 kcal/wk
- For female subjects: Pregnancy, breast feeding, or intent to get pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans
Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies.
Objective: The purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per day over 9 weeks, in subjects with hypercholesterolemia.
Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.
- Conditions
- Hypercholesterolemia
- Being tested
- Cardioviva™ supplement capsule, Placebo capsule
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioviva™ supplement capsuleDietary supplement
Twice per day (BID), 9 weeks
Placebo capsuleDietary supplement
Twice per day (BID), 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cardioviva™ supplement capsule | Experimental | Not described Receives: Dietary Supplement: Cardioviva™ supplement capsule |
| Placebo capsule | Placebo comparator | Not described Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micropharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341613
- Sponsor's protocol ID
- MP-0110
- Status last verified
- Nov 2011
- First submitted
- 22 Apr 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones ML, Martoni CJ, Ganopolsky JG, Sulemankhil I, Ghali P, Prakash S. Improvement of gastrointestinal health status in subjects consuming Lactobacillus reuteri NCIMB 30242 capsules: a post-hoc analysis of a randomized controlled trial. Expert Opin Biol Ther. 2013 Dec;13(12):1643-51. doi: 10.1517/14712598.2013.833601. Epub 2013 Sep 28.
PubMed 24074303Jones ML, Martoni CJ, Prakash S. Letter to the editor regarding the report of Duboc et al: Connecting dysbiosis, bile-acid dysmetabolism and gut inflammation in inflammatory bowel disease. Gut. 2013 Apr;62(4):654-5. doi: 10.1136/gutjnl-2012-303867. Epub 2012 Nov 12. No abstract available.
PubMed 23148122Jones ML, Martoni CJ, Di Pietro E, Simon RR, Prakash S. Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: a randomized control trial. Regul Toxicol Pharmacol. 2012 Jul;63(2):313-20. doi: 10.1016/j.yrtph.2012.04.003. Epub 2012 Apr 25.
PubMed 22561556
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Supplement Capsule Containing L. Reuteri Cardioviva™ on Managing Cholesterol Levels in Hypercholesterolemic Humans
- ClinicalTrials.gov ID
- NCT01341613
- Acronym / sponsor ID
- MP-0110
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Micropharma LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Apr 2011 (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.
Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies.
Objective: The purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per day over 9 weeks, in subjects with hypercholesterolemia.
Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioviva™ supplement capsule | Experimental | Dietary Supplement: Cardioviva™ supplement capsule |
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo capsule |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, aged 20 to 75 years (bounds included)
- LDL-Cholesterol above 3.4 mmol/L (<15% variation between visits V1 and V2-1)
- TG levels below 4.0 mmol/L (checked at visits V0 and V2-1)
- BMI range will be 22 to 32 kg/m²
- Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines)
Key exclusion criteria (13 listed)
- Use of cholesterol lowering prescription drugs other than statin monotherapy within the last 6 months
- Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription food supplements within last 3 months
- History of chronic use of alcohol (>2 drinks/d)
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin
- Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months
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 |
|---|---|---|
| Cardioviva™ supplement capsuleTwice per day (BID), 9 weeks | Dietary supplement | Cardioviva™ supplement capsule |
| Placebo capsuleTwice per day (BID), 9 weeks | Dietary supplement | Placebo capsule |
Primary outcome
The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Derived from this study: PubMed 24074303Jones ML, Martoni CJ, Ganopolsky JG, Sulemankhil I, Ghali P, Prakash S. Improvement of gastrointestinal health status in subjects consuming Lactobacillus reuteri NCIMB 30242 capsules: a post-hoc analysis of a randomized controlled trial. Expert Opin Biol Ther. 2013 Dec;13(12):1643-51. doi: 10.1517/14712598.2013.833601. Epub 2013 Sep 28.
- Derived from this study: PubMed 23148122Jones ML, Martoni CJ, Prakash S. Letter to the editor regarding the report of Duboc et al: Connecting dysbiosis, bile-acid dysmetabolism and gut inflammation in inflammatory bowel disease. Gut. 2013 Apr;62(4):654-5. doi: 10.1136/gutjnl-2012-303867. Epub 2012 Nov 12. No abstract available.
- Derived from this study: PubMed 22561556Jones ML, Martoni CJ, Di Pietro E, Simon RR, Prakash S. Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: a randomized control trial. Regul Toxicol Pharmacol. 2012 Jul;63(2):313-20. doi: 10.1016/j.yrtph.2012.04.003. Epub 2012 Apr 25.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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 2 study testing Cardioviva™ supplement capsule in people with Hypercholesterolemia, run by Micropharma Limited at 1 site in Czechia.
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 13 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 2 Nov 2011. 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 Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
The primary outcome will be the percent difference in LDL-cholesterol from baseline to endpoint comparing subjects receiving treatment and placebo (time frame: 9 weeks). 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 NCT01341613, 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 2 Nov 2011.