<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/NCT04461782</url>
  </required_header>
  <id_info>
    <org_study_id>AB-INTIMUS-Colonization</org_study_id>
    <nct_id>NCT04461782</nct_id>
  </id_info>
  <brief_title>Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota</brief_title>
  <official_title>Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AB Biotics, SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AB Biotics, SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota&#xD;
      gets altered, opportunistic microorganisms may proliferate and become abundant species giving&#xD;
      rise to dysbiosis.&#xD;
&#xD;
      Probiotics are living organisms that provide the host certain benefits. Despite probiotics&#xD;
      have been historically linked to intestinal microbiota, several research groups have&#xD;
      published positive results for some Lactobacillus strains in vaginal microbiota. The&#xD;
      Lactobacillus strain investigated in the presented project showed the ability to prevent&#xD;
      recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.&#xD;
&#xD;
      Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps,&#xD;
      however oral intake is widely preferred among consumers. Because of that, this study aims to&#xD;
      determine whether this Lactobacillus strain is able to colonize vaginal microbiota when&#xD;
      administered orally.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Colonization</measure>
    <time_frame>change day 14-23 from baseline</time_frame>
    <description>Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colonization</measure>
    <time_frame>change day 42 from baseline</time_frame>
    <description>Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lactobacillary grade (LBG) score</measure>
    <time_frame>change day 42 from baseline</time_frame>
    <description>obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other bacteria in vagina</measure>
    <time_frame>change day 14-23 from baseline</time_frame>
    <description>Detection of other bacteria by metagenomic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other bacteria in vagina</measure>
    <time_frame>change day 42 from baseline</time_frame>
    <description>Detection of other bacteria by metagenomic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal pH</measure>
    <time_frame>Change day 14-23 from baseline</time_frame>
    <description>Measured through urine test strip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal pH</measure>
    <time_frame>Change day 42 from baseline</time_frame>
    <description>Measured through urine test strip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Product satisfaction</measure>
    <time_frame>day 14-23</time_frame>
    <description>Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>through study completion, an average of 42 days</time_frame>
    <description>Analyzed by the number of adverse events registered during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>Change day 14-23 from baseline</time_frame>
    <description>Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Vaginal Infection</condition>
  <arm_group>
    <arm_group_label>Lactobacillus plantarum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral intake 1 cap daily&#xD;
1E+09 cfu/cap of Lactobacillus plantarum</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus plantarum</intervention_name>
    <description>Oral food supplement</description>
    <arm_group_label>Lactobacillus plantarum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade)&#xD;
             I, IIa or IIb.&#xD;
&#xD;
          -  Using the same contraceptive within 4 weeks prior to study start.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current vaginal infection.&#xD;
&#xD;
          -  Vaginal infection 1 month prior to study start.&#xD;
&#xD;
          -  Cervico-vaginal pathology.&#xD;
&#xD;
          -  Papilloma human virus.&#xD;
&#xD;
          -  Pregnant or breastfeeding mothers.&#xD;
&#xD;
          -  Using IUD.&#xD;
&#xD;
          -  Immunomodulators or systemic corticoids intake.&#xD;
&#xD;
          -  Vaginal or systemic antibiotics intake 1 month prior to study start.&#xD;
&#xD;
          -  Vaginal probiotic intake 1 month prior to study start.&#xD;
&#xD;
          -  Less than three months after giving birth or abortion.&#xD;
&#xD;
          -  Undergone vaginal or intestinal surgery three months prior to study start.&#xD;
&#xD;
          -  Severe stress or depression.&#xD;
&#xD;
          -  Systemic acute or severe disease.&#xD;
&#xD;
          -  History of alcohol or drug abuse.&#xD;
&#xD;
          -  Chronic intestinal pathology.&#xD;
&#xD;
          -  Not understanding protocol procedures.&#xD;
&#xD;
          -  Use of lubricant 24 hours or spermicide 7 days prior to study start.&#xD;
&#xD;
          -  Swallowing difficulties.&#xD;
&#xD;
          -  Impossibility to understand study procedures.&#xD;
&#xD;
          -  Enrolled in another clinical study.&#xD;
&#xD;
          -  Atrophic vaginitis not under treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Subjects must be female in order to sample vaginal microbiota</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sta María del Rosell university hospital</name>
      <address>
        <city>Cartagena</city>
        <zip>30203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. doi: 10.1136/pmj.79.934.428.</citation>
    <PMID>12954951</PMID>
  </reference>
  <reference>
    <citation>Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.</citation>
    <PMID>9553803</PMID>
  </reference>
  <reference>
    <citation>Palacios S, Espadaler J, Fernandez-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9.</citation>
    <PMID>27393491</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vaginal probiotic</keyword>
  <!-- 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/NCT04461782
org study id: AB-INTIMUS-Colonization
nct id: NCT04461782
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota
      gets altered, opportunistic microorganisms may proliferate and become abundant species giving
      rise to dysbiosis.

      Probiotics are living organisms that provide the host certain benefits. Despite probiotics
      have been historically linked to intestinal microbiota, several research groups have
      published positive results for some Lactobacillus strains in vaginal microbiota. The
      Lactobacillus strain investigated in the presented project showed the ability to prevent
      recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.

      Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps,
      however oral intake is widely preferred among consumers. Because of that, this study aims to
      determine whether this Lactobacillus strain is able to colonize vaginal microbiota when
      administered orally.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Colonization
time frame: change day 14-23 from baseline
description: Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
measure: Colonization
time frame: change day 42 from baseline
description: Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
measure: Lactobacillary grade (LBG) score
time frame: change day 42 from baseline
description: obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3.
measure: Other bacteria in vagina
time frame: change day 14-23 from baseline
description: Detection of other bacteria by metagenomic analysis
measure: Other bacteria in vagina
time frame: change day 42 from baseline
description: Detection of other bacteria by metagenomic analysis
measure: Vaginal pH
time frame: Change day 14-23 from baseline
description: Measured through urine test strip
measure: Vaginal pH
time frame: Change day 42 from baseline
description: Measured through urine test strip
measure: Product satisfaction
time frame: day 14-23
description: Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied
measure: Safety and tolerability
time frame: through study completion, an average of 42 days
description: Analyzed by the number of adverse events registered during the study
measure: Gastrointestinal symptoms
time frame: Change day 14-23 from baseline
description: Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc)
arm group label: Lactobacillus plantarum
arm group type: Experimental
description: Oral intake 1 cap daily
1E+09 cfu/cap of Lactobacillus plantarum
intervention type: Dietary Supplement
intervention name: Lactobacillus plantarum
description: Oral food supplement
arm group label: Lactobacillus plantarum
criteria: 
gender: Female
gender based: Yes
gender description: Subjects must be female in order to sample vaginal microbiota
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
citation: Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. doi: 10.1136/pmj.79.934.428.
PMID: 12954951
citation: Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.
PMID: 9553803
citation: Palacios S, Espadaler J, Fernandez-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9.
PMID: 27393491
responsible party type: Sponsor