HypercholesterolemiaPhase 4NCT01849185
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
A Phase 4 study testing Food supplement in people with Hypercholesterolemia, run by Meir Medical Center at 1 site in Israel.
Trial summary
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Mar 2014
- Phase
- Phase 4
- 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
- 1) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.
Who cannot join
- Patients on chronic antibiotic treatment
- Patients with immune disorders
- Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia.
- Patients who experienced myocardial infarction within less than two months.
- Patients who consume probiotics.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin
- Conditions
- Hypercholesterolemia
- Being tested
- Food supplement
- Keywords
- Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementOther
Also called BIO-25
| Study group | Role | What they receive |
|---|---|---|
| BIO 25 (food supplements)twice a day for 8 weeks | Active comparator | BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule. Receives: Other: Food supplement |
| Placebo twice a day for 8 weeks | Placebo comparator | Placebo twice a day for 8 weeks Receives: Other: Food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-Cholesterol levels.
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
Measured: 8 weeks
Secondary outcomes (1)
Hemoglobin A1C
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana Berlin, MD, Principal investigator, Division of Cardiology Meir MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849185
- Sponsor's protocol ID
- mmc120213ctil
- Status last verified
- May 2013
- First submitted
- 5 May 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01849185
- Acronym / sponsor ID
- mmc120213ctil
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 May 2013 (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.
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIO 25 (food supplements)twice a day for 8 weeks | Active comparator | Other: Food supplementBIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule. |
| Placebo twice a day for 8 weeks | Placebo comparator | Other: Food supplementPlacebo twice a day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.
Key exclusion criteria (5 listed)
- Patients on chronic antibiotic treatment
- Patients with immune disorders
- Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia.
- Patients who experienced myocardial infarction within less than two months.
- Patients who consume probiotics.
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 |
|---|---|---|
| Food supplementAlso: BIO-25 | Other | BIO 25 (food supplements)twice a day for 8 weeks, Placebo twice a day for 8 weeks |
Primary outcome
LDL-Cholesterol levels.
Time frame: 8 weeks
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
1 secondary outcome
Hemoglobin A1C
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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.
Tatiana Berlin, MD principal investigator
Division of Cardiology Meir MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Food supplement in people with Hypercholesterolemia, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 May 2013. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morris Mosseri, MD (97297472587, morris.mosseri@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-Cholesterol levels. (time frame: 8 weeks). 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 8 May 2013.