NCT02216825已完成2 期
Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- The primary outcome will be the change in plasma bile acid profile from baseline to endpoint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
The primary outcome will be the change in plasma bile acid profile from baseline to endpoint
时间窗: Week 0 and Week 4 of intervention period
次要结局
未报告次要终点
研究者
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