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

NCT02216825 | Completed Phase 2

• 1 other identifier: MP-12LCHMe
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the change in plasma bile acid profile from baseline to endpoint

  Week 0 and Week 4 of intervention period

Study Arms (2)

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

Interventions

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Micropharma Limited: lead

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-06