Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Delayed release capsule, L. reuteri NCIMB 30242, escalated dose; Dietary Supplement: Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose

• Registration Number: NCT02216825
• Lead Sponsor: Micropharma Limited

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2013-12
• Status Verified: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Study First Posted: 2014-08-15
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed release capsule, L. reuteri NCIMB 30242	Delayed release capsule, L. reuteri NCIMB 30242, escalated dose	-
Standard vegetarian capsule, L. reuteri NCIMB 30242	Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose	-

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the change in plasma bile acid profile from baseline to endpoint	Week 0 and Week 4 of intervention period