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

NCT02216825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-08-15

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Delayed release capsule, L. reuteri NCIMB 30242, escalated dose

DIETARY_SUPPLEMENT

Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose

Sponsors & Collaborators

  • Micropharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-12-31
Completion
2014-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216825 on ClinicalTrials.gov