DyslipidemiaPhase 1/2NCT02048410
Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
A Phase 1/2 study testing Lactobacillus paracasei B21060 and low satured diet in people with Dyslipidemia and Familial Hypercholesterolemia, run by Federico II University.
Trial summary
Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Familial Hypercholesterolemia
- What is being tested?
- Lactobacillus paracasei B21060 and low satured diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 1/2
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged ≥ 6 and ≤ 12 years.
- Diagnosis of hypercholesterolemia (LDL cholesterol> 140 mg / dl)
- Each patient must have shown resistance to dietary therapy lasting at least 6-12 months.
Who cannot join
- Age <6 or> 12 years.
- Patients undergoing drug treatment for hypercholesterolemia.
- Any medical condition that may interfere with participation in this study
- Participation in clinical trials still in progress.
- Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment
About this study
Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).
Read the detailed description
FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.
- Conditions
- Dyslipidemia, Familial Hypercholesterolemia
- Being tested
- Lactobacillus paracasei B21060, low satured diet
- Medical subject headings
- Dyslipidemias, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei B21060Dietary supplement
combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)
low satured dietOther
| Study group | Role | What they receive |
|---|---|---|
| diet plus Lactobacillus paracasei B21060 | Active comparator | low saturated fats diet plus the symbiotic (2.5×109cfu, bid) Receives: Dietary Supplement: Lactobacillus paracasei B21060; Other: low satured diet |
| low saturated fats diet | Placebo comparator | low saturated fats diet Receives: Other: low satured diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of LDL cholesterol after 6 months of treatment wiyh symbiotic
Measured: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
- Investigators
- Roberto berni canani, MD,Phd, Principal investigator, university of naples federicoII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048410
- Sponsor's protocol ID
- 9/14
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2014
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT02048410
- Acronym / sponsor ID
- 9/14
- Conditions
- Dyslipidemia, Familial Hypercholesterolemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jan 2014 (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.
Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).
Detailed description
FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet plus Lactobacillus paracasei B21060 | Active comparator | Dietary Supplement: Lactobacillus paracasei B21060, Other: low satured dietlow saturated fats diet plus the symbiotic (2.5×109cfu, bid) |
| low saturated fats diet | Placebo comparator | Other: low satured dietlow saturated fats diet |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged ≥ 6 and ≤ 12 years.
- Diagnosis of hypercholesterolemia (LDL cholesterol> 140 mg / dl)
- Each patient must have shown resistance to dietary therapy lasting at least 6-12 months.
Key exclusion criteria (5 listed)
- Age <6 or> 12 years.
- Patients undergoing drug treatment for hypercholesterolemia.
- Any medical condition that may interfere with participation in this study
- Participation in clinical trials still in progress.
- Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment
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 paracasei B21060combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine) | Dietary supplement | diet plus Lactobacillus paracasei B21060 |
| low satured diet | Other | diet plus Lactobacillus paracasei B21060, low saturated fats diet |
Primary outcome
change of LDL cholesterol after 6 months of treatment wiyh symbiotic
Time frame: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.
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 29 Jan 2014.
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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.
Roberto berni canani, MD,Phd principal investigator
university of naples federicoII
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus paracasei B21060 and low satured diet in people with Dyslipidemia and Familial Hypercholesterolemia, run by Federico II University.
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 3 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: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
change of LDL cholesterol after 6 months of treatment wiyh symbiotic (time frame: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.). 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 29 Jan 2014.