<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/NCT04506385</url>
  </required_header>
  <id_info>
    <org_study_id>294/CE</org_study_id>
    <nct_id>NCT04506385</nct_id>
  </id_info>
  <brief_title>Metabolomic Effects of Probiotics Administration</brief_title>
  <acronym>MAPPINg</acronym>
  <official_title>Effects of Probiotics Administration on Human Metabolic Phenotype</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Probiotical S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Probiotical S.p.A.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The establishment of the beneficial interactions between the host and its&#xD;
      microbiota is essential for the development and correct functioning of the organism, since&#xD;
      microflora alterations can lead to many chronic degenerative diseases. In this context,&#xD;
      probiotics are used to improve balanced microbial communities and therefore exert substantial&#xD;
      health-promoting effects to the host.&#xD;
&#xD;
      Objective: The aim of the present study is to monitor the molecular outcomes, obtained by gut&#xD;
      microflora modulation through probiotic treatment, on human urine and serum metabolic&#xD;
      profiles, with a 1H-Nuclear Magnetic Resonance -based metabolomic approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: In a first phase twenty-two healthy subjects are enrolled in the study and&#xD;
      administered with Lactobacillus delbrueckii subs. delbrueckii and/or a mix of 5 biotypes of&#xD;
      Bifidobacterium longum for 8 weeks. In the second phase subjects are enrolled in the study&#xD;
      and administered with Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus&#xD;
      fermentum and Bifidobacterium longum at two different concentration. During the course of the&#xD;
      study all the probiotic types were administered both singularly and in combination. From each&#xD;
      subject urine and serum samples are collected before and during the supplementation and are&#xD;
      analysed by nuclear magnetic resonance spectroscopy and statistical analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>metabolomic profile</measure>
    <time_frame>20 days</time_frame>
    <description>To monitor the molecular outcomes, obtained by gut microflora modulation through probiotic treatment, on human urine and serum metabolic profiles, with a 1H-Nuclear Magnetic Resonance-based metabolomic approach</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Metabolomic Profile</condition>
  <arm_group>
    <arm_group_label>A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>L. delbrueckii LDD01 probiotic bacterial strain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bifidobacterium longum DLBL probiotic bacterial strain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum 04: low dosage; probiotic bacterial strains blend</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum BL04: high dosage; probiotic bacterial strains blend</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>probiotics</intervention_name>
    <description>In the first phase: 10 subjects have added in the diet a daily dose of 1 billion of freeze-dried LDD01 probiotics (A arm), 12 individuals are supplemented with a daily dose of 1 billion of the DLBL mix (B arm). In the second phase: 10 individuals are supplemented with a daily low dose of probiotics blend (C arm) and 10 individuals are supplemented with a daily high dose of probiotics blend (D arm).</description>
    <arm_group_label>A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams</arm_group_label>
    <arm_group_label>B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams</arm_group_label>
    <arm_group_label>C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams</arm_group_label>
    <arm_group_label>D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgery on the intestinal tract;&#xD;
&#xD;
          -  a probiotic / prebiotic and antibiotic treatments within 3 and 1 months, respectively,&#xD;
             before the beginning of the study;&#xD;
&#xD;
          -  subjects have changed drastically their diet or lifestyle during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda Ospedaliera-Universitaria Maggiore della carità di Novara</name>
      <address>
        <city>Novara</city>
        <state>Piemonte</state>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04506385
org study id: 294/CE
nct id: NCT04506385
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Background: The establishment of the beneficial interactions between the host and its
      microbiota is essential for the development and correct functioning of the organism, since
      microflora alterations can lead to many chronic degenerative diseases. In this context,
      probiotics are used to improve balanced microbial communities and therefore exert substantial
      health-promoting effects to the host.

      Objective: The aim of the present study is to monitor the molecular outcomes, obtained by gut
      microflora modulation through probiotic treatment, on human urine and serum metabolic
      profiles, with a 1H-Nuclear Magnetic Resonance -based metabolomic approach.
Design: In a first phase twenty-two healthy subjects are enrolled in the study and
      administered with Lactobacillus delbrueckii subs. delbrueckii and/or a mix of 5 biotypes of
      Bifidobacterium longum for 8 weeks. In the second phase subjects are enrolled in the study
      and administered with Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus
      fermentum and Bifidobacterium longum at two different concentration. During the course of the
      study all the probiotic types were administered both singularly and in combination. From each
      subject urine and serum samples are collected before and during the supplementation and are
      analysed by nuclear magnetic resonance spectroscopy and statistical analyses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: metabolomic profile
time frame: 20 days
description: To monitor the molecular outcomes, obtained by gut microflora modulation through probiotic treatment, on human urine and serum metabolic profiles, with a 1H-Nuclear Magnetic Resonance-based metabolomic approach
arm group label: A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams
arm group type: Active Comparator
description: L. delbrueckii LDD01 probiotic bacterial strain
arm group label: B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams
arm group type: Active Comparator
description: Bifidobacterium longum DLBL probiotic bacterial strain
arm group label: C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams
arm group type: Active Comparator
description: L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum 04: low dosage; probiotic bacterial strains blend
arm group label: D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams
arm group type: Active Comparator
description: L. plantarum LP01, L.fermentum LF16, L. rhamnosus LR06 and B. longum BL04: high dosage; probiotic bacterial strains blend
intervention type: Dietary Supplement
intervention name: probiotics
description: In the first phase: 10 subjects have added in the diet a daily dose of 1 billion of freeze-dried LDD01 probiotics (A arm), 12 individuals are supplemented with a daily dose of 1 billion of the DLBL mix (B arm). In the second phase: 10 individuals are supplemented with a daily low dose of probiotics blend (C arm) and 10 individuals are supplemented with a daily high dose of probiotics blend (D arm).
arm group label: A - L. delbrueckii LDD01 probiotic bacterial strain administered in sachets of 2 grams
arm group label: B - Bifidobacterium longum DLBL probiotic bacterial strain administered in sachets of 2 grams
arm group label: C - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams
arm group label: D - LP01, LF16, LR06 and B. longum 04 administered in sachets of 2 grams
criteria: 
gender: All
minimum age: 24 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: No