<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/NCT03019172</url>
  </required_header>
  <id_info>
    <org_study_id>UTIReuteri2016</org_study_id>
    <nct_id>NCT03019172</nct_id>
  </id_info>
  <brief_title>Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women</brief_title>
  <acronym>UTIReuteri</acronym>
  <official_title>Safety, and Effectiveness of Lactobacillus Reuteri for the Treatment of Urinary Tract Infections in Women: A Pilot Randomized Clinical Trial (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovacion y Desarrollo de Estrategias en Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovacion y Desarrollo de Estrategias en Salud</source>
  <oversight_info>
    <has_dmc>Yes</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>
      RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 &amp; Lactobacillus&#xD;
      reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure&#xD;
      in women with non complicated acute cystitis who receive probiotics for 12 days compared with&#xD;
      the frequency in women who receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy&#xD;
      of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency&#xD;
      of clinical or bacteriological cure. Secondary outcomes will be a) time to&#xD;
      clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who&#xD;
      receive probiotics for 12 days compared with the time in women who receive placebo; b)&#xD;
      frequency of clinical/laboratory and bacteriologic relapse in women with non complicated&#xD;
      acute cystitis who receive probiotics for 12 days compared with the frequency in women who&#xD;
      receive placebo, at day 30 after treatment start and c) frequency of adverse related events&#xD;
      in women with non complicated acute cystitis who receive probiotics for 12 days compared with&#xD;
      the frequency in women who receive placebo. In the active product we will use 5*10^8 CFU of&#xD;
      Lactobacillus reuteri DSM 16666 &amp; Lactobacillus reuteri DSM 17938 + cranberry extract. The&#xD;
      control group will recibe Cranberry extract. The products will be taken twice per day,&#xD;
      morning and evening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</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>
    <intervention_model_description>Randomized controlled trial, double blind allocation concealment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical and bacteriological cure</measure>
    <time_frame>30 days</time_frame>
    <description>Frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical or bacteriological relapse</measure>
    <time_frame>30 days</time_frame>
    <description>Time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>14 days</time_frame>
    <description>• Frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>Lactobacillus reuteri</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in experimental branch will receive two sachets. Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 &amp; Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sachet with cranberry + placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women in control branch will receive two sachets. Sachet one contains only Maltodextrin and sachet two contains instant cranberry drinkcomposed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica Both sachets should be emptied in a glass and mixed with 200 ml of cold water</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Lactobacillus reuteri</intervention_name>
    <description>Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 &amp; Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5*10^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc</description>
    <arm_group_label>Lactobacillus reuteri</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sachet with cranberry + placebo</intervention_name>
    <description>Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.</description>
    <arm_group_label>Sachet with cranberry + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non pregnant pre menopausal women&#xD;
&#xD;
          -  Minimum age 18 years&#xD;
&#xD;
          -  Uncomplicated cystitis diagnosed by urine dipstick testing (nitrates +, leukocytes&#xD;
             esterase&#xD;
&#xD;
               -  and/or 105 CFU/ml or nitrates +, leukocytes esterase + and/or 102 -103 CFU/ml+&#xD;
                  clinical symptoms) and an evaluation of the presence of typical related symptoms.&#xD;
                  In particular, frequency (frequent voiding of urine), urgency (the urge to void&#xD;
                  immediately), dysuria (painful voiding), and/or suprapubic pain.&#xD;
&#xD;
          -  Verbal and Written Informed Consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute cystitis symptoms for &gt;1week before the first visit&#xD;
&#xD;
          -  Diabetes mellitus,&#xD;
&#xD;
          -  Congenital urinary tract abnormality&#xD;
&#xD;
          -  Lactating women&#xD;
&#xD;
          -  Female who intend to become pregnant during the study or within 3 months after the&#xD;
             completion of the study&#xD;
&#xD;
          -  Vaginal discharge + fever (&gt;37.5oC)&#xD;
&#xD;
          -  Diagnostic of sexually transmitted diseases&#xD;
&#xD;
          -  Use of an indwelling catheter or an intermittent self-catheterisation program&#xD;
&#xD;
          -  Presence of neurogenic bladder, or&#xD;
&#xD;
          -  Use of any antibiotic 2 weeks before Day 1 in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital General Dr. Manuel Gea Gonzalez</name>
      <address>
        <city>Mexico city</city>
        <state>Tlalpan</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Lee BB, Toh SL, Ryan S, Simpson JM, Clezy K, Bossa L, Rice SA, Marial O, Weber G, Kaur J, Boswell-Ruys C, Goodall S, Middleton J, Tudehope M, Kotsiou G. Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial. BMC Urol. 2016 Apr 16;16:18. doi: 10.1186/s12894-016-0136-8.</citation>
    <PMID>27084704</PMID>
  </reference>
  <reference>
    <citation>Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.</citation>
    <PMID>26695595</PMID>
  </reference>
  <reference>
    <citation>Chisholm AH. Probiotics in Preventing Recurrent Urinary Tract Infections in Women: A Literature Review. Urol Nurs. 2015 Jan-Feb;35(1):18-21, 29.</citation>
    <PMID>26298938</PMID>
  </reference>
  <reference>
    <citation>Vicariotto F. Effectiveness of an association of a cranberry dry extract, D-mannose, and the two microorganisms Lactobacillus plantarum LP01 and Lactobacillus paracasei LPC09 in women affected by cystitis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S96-101. doi: 10.1097/MCG.0000000000000224.</citation>
    <PMID>25291140</PMID>
  </reference>
  <reference>
    <citation>Grin PM, Kowalewska PM, Alhazzan W, Fox-Robichaud AE. Lactobacillus for preventing recurrent urinary tract infections in women: meta-analysis. Can J Urol. 2013 Feb;20(1):6607-14.</citation>
    <PMID>23433130</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>November 27, 2017</last_update_submitted>
  <last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Innovacion y Desarrollo de Estrategias en Salud</investigator_affiliation>
    <investigator_full_name>Pedro Gutierrez Castrellon</investigator_full_name>
    <investigator_title>MD, MSc, DSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <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/NCT03019172
org study id: UTIReuteri2016
nct id: NCT03019172
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 & Lactobacillus
      reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure
      in women with non complicated acute cystitis who receive probiotics for 12 days compared with
      the frequency in women who receive placebo.
Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy
      of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency
      of clinical or bacteriological cure. Secondary outcomes will be a) time to
      clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who
      receive probiotics for 12 days compared with the time in women who receive placebo; b)
      frequency of clinical/laboratory and bacteriologic relapse in women with non complicated
      acute cystitis who receive probiotics for 12 days compared with the frequency in women who
      receive placebo, at day 30 after treatment start and c) frequency of adverse related events
      in women with non complicated acute cystitis who receive probiotics for 12 days compared with
      the frequency in women who receive placebo. In the active product we will use 5*10^8 CFU of
      Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938 + cranberry extract. The
      control group will recibe Cranberry extract. The products will be taken twice per day,
      morning and evening.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial, double blind allocation concealment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: clinical and bacteriological cure
time frame: 30 days
description: Frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo
measure: clinical or bacteriological relapse
time frame: 30 days
description: Time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo
measure: Adverse events
time frame: 14 days
description: • Frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo
arm group label: Lactobacillus reuteri
arm group type: Experimental
description: Women in experimental branch will receive two sachets. Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
arm group label: Sachet with cranberry + placebo
arm group type: Placebo Comparator
description: Women in control branch will receive two sachets. Sachet one contains only Maltodextrin and sachet two contains instant cranberry drinkcomposed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica Both sachets should be emptied in a glass and mixed with 200 ml of cold water
intervention type: Combination Product
intervention name: Lactobacillus reuteri
description: Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5*10^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc
arm group label: Lactobacillus reuteri
intervention type: Dietary Supplement
intervention name: Sachet with cranberry + placebo
description: Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
arm group label: Sachet with cranberry + placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Mexico
citation: Lee BB, Toh SL, Ryan S, Simpson JM, Clezy K, Bossa L, Rice SA, Marial O, Weber G, Kaur J, Boswell-Ruys C, Goodall S, Middleton J, Tudehope M, Kotsiou G. Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a study protocol for a randomised controlled trial. BMC Urol. 2016 Apr 16;16:18. doi: 10.1186/s12894-016-0136-8.
PMID: 27084704
citation: Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.
PMID: 26695595
citation: Chisholm AH. Probiotics in Preventing Recurrent Urinary Tract Infections in Women: A Literature Review. Urol Nurs. 2015 Jan-Feb;35(1):18-21, 29.
PMID: 26298938
citation: Vicariotto F. Effectiveness of an association of a cranberry dry extract, D-mannose, and the two microorganisms Lactobacillus plantarum LP01 and Lactobacillus paracasei LPC09 in women affected by cystitis: a pilot study. J Clin Gastroenterol. 2014 Nov-Dec;48 Suppl 1:S96-101. doi: 10.1097/MCG.0000000000000224.
PMID: 25291140
citation: Grin PM, Kowalewska PM, Alhazzan W, Fox-Robichaud AE. Lactobacillus for preventing recurrent urinary tract infections in women: meta-analysis. Can J Urol. 2013 Feb;20(1):6607-14.
PMID: 23433130
responsible party type: Principal Investigator
investigator affiliation: Innovacion y Desarrollo de Estrategias en Salud
investigator full name: Pedro Gutierrez Castrellon
investigator title: MD, MSc, DSc
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
sharing ipd: No