HypercholesterolemiaPhase 2NCT02216825
Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile
A Phase 2 study testing Delayed release capsule, L. reuteri NCIMB 30242, escalated dose and Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose in people with Hypercholesterolemia, run by Micropharma Limited.
Trial summary
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Delayed release capsule, L. reuteri NCIMB 30242, escalated dose and Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jun 2014
- 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
- Adult, Older adult
Who may be able to join
- Males and females, aged 20 to 75 years (bounds included).
- LDL-C ≥ 3.40 mmol/L.
- TG < 4.00 mmol/L.
- TBA < 10 umol/L.
- BMI range from 23.0 to 32.5 kg/m2 (bounds included).
- 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.
- Female subjects not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Female subject of childbearing potential who agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System); Intrauterine devices; Vasectomy of partner; Total abstinence.
Who cannot join
- Use of cholesterol lowering prescription drugs 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 supplements within last 1 month.
- History of chronic use of alcohol (> 2 drinks/d).
- History of heavy smoking (≥ 20 cigarettes/d).
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
- Immune-compromised subjects (e.g. AIDS, lymphoma, subjects undergoing long-term corticosteroid treatment)
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- Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months.
- Subjects with elevated LDL-C (≥ 3.40 mmol/L) and high (>20%) CVD risk estimated by the Framingham risk score
- Previously diagnosed Type I or Type II diabetes.
- 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).
- Clinically significant abnormal laboratory results at screening.
- 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.
- Female subjects that are pregnant, breast feeding or intend to get pregnant.
- Allergy or sensitivity to test product ingredients
- Allergy or sensitivity to all 3 antibiotics (Clindamycin, Erythromycin and Ampicillin).
About this study
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.
Objective: The purpose of the study is to investigate the effect of a delayed release or standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over a 4 week period, on the plasma bile acid profile.
Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The study will last a total of 6 weeks, including a 4-week intervention period and a 2-week washout period.
- Conditions
- Hypercholesterolemia
- Being tested
- Delayed release capsule, L. reuteri NCIMB 30242, escalated dose, Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed release capsule, L. reuteri NCIMB 30242, escalated doseDietary supplement
Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated doseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Delayed release capsule, L. reuteri NCIMB 30242 | Experimental | Not described Receives: Dietary Supplement: Delayed release capsule, L. reuteri NCIMB 30242, escalated dose |
| Standard vegetarian capsule, L. reuteri NCIMB 30242 | Experimental | Not described Receives: Dietary Supplement: Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the change in plasma bile acid profile from baseline to endpoint
Measured: Week 0 and Week 4 of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionJun 2014
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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT02216825
- Sponsor's protocol ID
- MP-12LCHMe
- Status last verified
- Jun 2014
- First submitted
- 12 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile
- ClinicalTrials.gov ID
- NCT02216825
- Acronym / sponsor ID
- MP-12LCHMe
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Micropharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Aug 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.
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.
Objective: The purpose of the study is to investigate the effect of a delayed release or standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over a 4 week period, on the plasma bile acid profile.
Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The study will last a total of 6 weeks, including a 4-week intervention period and a 2-week washout period.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed release capsule, L. reuteri NCIMB 30242 | Experimental | Dietary Supplement: Delayed release capsule, L. reuteri NCIMB 30242, escalated dose |
| Standard vegetarian capsule, L. reuteri NCIMB 30242 | Experimental | Dietary Supplement: Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females, aged 20 to 75 years (bounds included).
- LDL-C ≥ 3.40 mmol/L.
- TG < 4.00 mmol/L.
- TBA < 10 umol/L.
- BMI range from 23.0 to 32.5 kg/m2 (bounds included).
Key exclusion criteria (19 listed)
- Use of cholesterol lowering prescription drugs 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 supplements within last 1 month.
- History of chronic use of alcohol (> 2 drinks/d).
- History of heavy smoking (≥ 20 cigarettes/d).
- Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
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 |
|---|---|---|
| Delayed release capsule, L. reuteri NCIMB 30242, escalated dose | Dietary supplement | Delayed release capsule, L. reuteri NCIMB 30242 |
| Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose | Dietary supplement | Standard vegetarian capsule, L. reuteri NCIMB 30242 |
Primary outcome
The primary outcome will be the change in plasma bile acid profile from baseline to endpoint
Time frame: Week 0 and Week 4 of intervention period
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 15 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delayed release capsule, L. reuteri NCIMB 30242, escalated dose and Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose in people with Hypercholesterolemia, run by Micropharma Limited.
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 8 inclusion and 19 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 15 Aug 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. 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 change in plasma bile acid profile from baseline to endpoint (time frame: Week 0 and Week 4 of intervention period). 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 15 Aug 2014.