<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216825</url>
  </required_header>
  <id_info>
    <org_study_id>MP-12LCHMe</org_study_id>
    <nct_id>NCT02216825</nct_id>
  </id_info>
  <brief_title>Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Micropharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Micropharma Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: In recent years, probiotics have shown promise in treating a variety of diseases.&#xD;
      Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase&#xD;
      active Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in&#xD;
      hypercholesterolemic adults.&#xD;
&#xD;
      Objective: The purpose of the study is to investigate the effect of a delayed release or&#xD;
      standard vegetarian capsule containing L. reuteri NCIMB 30242, taken in escalated dose over a&#xD;
      4 week period, on the plasma bile acid profile.&#xD;
&#xD;
      Design: The study design is a pilot, randomized, double-blind, dose-escalation study. The&#xD;
      study will last a total of 6 weeks, including a 4-week intervention period and a 2-week&#xD;
      washout period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome will be the change in plasma bile acid profile from baseline to endpoint</measure>
    <time_frame>Week 0 and Week 4 of intervention period</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Delayed release capsule, L. reuteri NCIMB 30242</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard vegetarian capsule, L. reuteri NCIMB 30242</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Delayed release capsule, L. reuteri NCIMB 30242, escalated dose</intervention_name>
    <arm_group_label>Delayed release capsule, L. reuteri NCIMB 30242</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose</intervention_name>
    <arm_group_label>Standard vegetarian capsule, L. reuteri NCIMB 30242</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, aged 20 to 75 years (bounds included).&#xD;
&#xD;
          -  LDL-C ≥ 3.40 mmol/L.&#xD;
&#xD;
          -  TG &lt; 4.00 mmol/L.&#xD;
&#xD;
          -  TBA &lt; 10 umol/L.&#xD;
&#xD;
          -  BMI range from 23.0 to 32.5 kg/m2 (bounds included).&#xD;
&#xD;
          -  Signed informed consent form prior to inclusion in the study.&#xD;
&#xD;
          -  Note: Subjects will be permitted to take stable doses of thyroid hormone and&#xD;
             anti-hypertensive agents, as long as these are continued equivalently throughout the&#xD;
             duration of study.&#xD;
&#xD;
          -  Female subjects not of child bearing potential. Defined as females who have had a&#xD;
             hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural&#xD;
             or surgically with &gt; 1 year since last menstruation) OR Female subject of childbearing&#xD;
             potential who agree to use a medically approved method of birth control and have a&#xD;
             negative urine pregnancy test result. Acceptable methods of birth control include:&#xD;
             Hormonal contraceptives including oral contraceptives, hormone birth control patch&#xD;
             (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives&#xD;
             (Depo-Provera, Lunelle), or hormone implant (Norplant System); Intrauterine devices;&#xD;
             Vasectomy of partner; Total abstinence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of cholesterol lowering prescription drugs within the last 6 months.&#xD;
&#xD;
          -  Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed&#xD;
             husk, or other cholesterol lowering non-prescription supplements within last 1 month.&#xD;
&#xD;
          -  History of chronic use of alcohol (&gt; 2 drinks/d).&#xD;
&#xD;
          -  History of heavy smoking (≥ 20 cigarettes/d).&#xD;
&#xD;
          -  Use of systemic antibodies, corticosteroids, androgens, or phenytoin.&#xD;
&#xD;
          -  Immune-compromised subjects (e.g. AIDS, lymphoma, subjects undergoing long-term&#xD;
             corticosteroid treatment)&#xD;
&#xD;
          -  Subject having experienced any cardiovascular event (Myocardial infarction, coronary&#xD;
             artery bypass, or other major surgical procedures) in the last 6 months.&#xD;
&#xD;
          -  Subjects with elevated LDL-C (≥ 3.40 mmol/L) and high (&gt;20%) CVD risk estimated by the&#xD;
             Framingham risk score&#xD;
&#xD;
          -  Previously diagnosed Type I or Type II diabetes.&#xD;
&#xD;
          -  Subject receiving systemic treatment or topical treatment likely to interfere with&#xD;
             evaluation of the study parameters.&#xD;
&#xD;
          -  Subject currently involved in a clinical trial or in an exclusion period following&#xD;
             participation in another clinical trial.&#xD;
&#xD;
          -  History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis,&#xD;
             gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of&#xD;
             active lesions, chemotherapy or surgery in the past year).&#xD;
&#xD;
          -  Clinically significant abnormal laboratory results at screening.&#xD;
&#xD;
          -  Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant&#xD;
             laxatives.&#xD;
&#xD;
          -  History of eating disorders.&#xD;
&#xD;
          -  Exercise greater than 15 miles/wk or 4,000 kcal/wk.&#xD;
&#xD;
          -  Female subjects that are pregnant, breast feeding or intend to get pregnant.&#xD;
&#xD;
          -  Allergy or sensitivity to test product ingredients&#xD;
&#xD;
          -  Allergy or sensitivity to all 3 antibiotics (Clindamycin, Erythromycin and&#xD;
             Ampicillin).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216825
org study id: MP-12LCHMe
nct id: NCT02216825
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: The primary outcome will be the change in plasma bile acid profile from baseline to endpoint
time frame: Week 0 and Week 4 of intervention period
arm group label: Delayed release capsule, L. reuteri NCIMB 30242
arm group type: Experimental
arm group label: Standard vegetarian capsule, L. reuteri NCIMB 30242
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Delayed release capsule, L. reuteri NCIMB 30242, escalated dose
arm group label: Delayed release capsule, L. reuteri NCIMB 30242
intervention type: Dietary Supplement
intervention name: Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose
arm group label: Standard vegetarian capsule, L. reuteri NCIMB 30242
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
responsible party type: Sponsor
mesh term: Hypercholesterolemia