Status:
COMPLETED
Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile
Lead Sponsor:
Micropharma Limited
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief 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 Lactoba...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- 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).
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02216825
Start Date
November 1 2013
End Date
June 1 2014
Last Update
August 15 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.