effect of l. reuteri ncimb 30242 on plasma bile acid profile

Conditions: Hypercholesterolemia

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. 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.


Eligibility criteria:
inclusion criteria: * 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 criteria: * 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).