xml: <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/NCT05999097</url>
    </required_header>
    <id_info>
      <org_study_id>030C-06/23</org_study_id>
      <nct_id>NCT05999097</nct_id>
    </id_info>
    <brief_title>To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome</brief_title>
    <official_title>To Study the Clinical Effect of SC-FOS Prebiotics in Enteral Diet vs. Standard Enteral Diet on Clinical Characteristics of Patients With Polycystic Ovary Syndrome According to the Rotterdam Classification in Chihuahua, Chihuahua. A Randomized Single-Blind Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Autonoma de Chihuahua</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Autonoma de Chihuahua</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>
        The purpose of this study is to determine if there is a difference in the clinical&#xD;
        characteristics of patients with polycystic ovary syndrome after the administration of SC-FOS&#xD;
        in the enteral diet compared to patients with a standard diet.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The protocol will be discussed with the patients and/or relatives of the patients, who will&#xD;
        understand the consequences and advantages of the study and will thus sign the consent.&#xD;
  &#xD;
        Once informed consent has been obtained, the group to which each patient belongs will be&#xD;
        randomly assigned.&#xD;
  &#xD;
        Patients will be selected according to the inclusion and exclusion criteria of the population&#xD;
        diagnosed with PCOS with useful enteral route for random assignment into two groups, one will&#xD;
        be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours, another&#xD;
        group will be given saline as a placebo to the enteral diet every 24 hours for 10 days.&#xD;
        Patients should take the solution on an empty stomach.&#xD;
  &#xD;
        Once the type of intervention has been determined, the patient will be given the suspensions&#xD;
        corresponding to group 1 or placebo, with vials in which the content cannot be visualized,&#xD;
        numbered according to the sheet obtained by the corresponding randomization. The initial&#xD;
        evaluation will be completed with all the clinical characteristics to be evaluated.&#xD;
  &#xD;
        The patient will be told that every 24 hours he must take 1 suspension on an empty stomach,&#xD;
        which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the&#xD;
        prebiotic preparation vs 15 cc of saline solution for the placebo group. The solution will be&#xD;
        administered enterally for 10 consecutive days at a single dose per day, and a reassessment&#xD;
        will be made on the seventh day of the clinical characteristics of the patients, to compare&#xD;
        and evaluate the results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2023</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>Prospective study, randomized single blind clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single (Participant)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Score of Bristol Scale</measure>
      <time_frame>10 days</time_frame>
      <description>Score obtained by Stool Consistency Bristol Scale:&#xD;
  This scale consist in seven types of stool:&#xD;
  Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Score Short Form Health Survey (SF-36)</measure>
      <time_frame>10 days</time_frame>
      <description>Short Form Health Survey (SF-36) is a measure of health-related quality-of-life:&#xD;
  It comprises 36 questions that cover eight domains of health&#xD;
  Limitations in physical activities because of health problems.&#xD;
  Limitations in social activities because of physical or emotional problems&#xD;
  Limitations in usual role activities because of physical health problems&#xD;
  Bodily pain&#xD;
  General mental health (psychological distress and well-being)&#xD;
  Limitations in usual role activities because of emotional problems&#xD;
  Vitality (energy and fatigue)&#xD;
  General health perceptions</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>Short Chain Fructooligosaccharides Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Short Chain Fructooligosaccharides</intervention_name>
      <description>The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.</description>
      <arm_group_label>Short Chain Fructooligosaccharides Group</arm_group_label>
      <other_name>Prebiotics</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo Group</intervention_name>
      <description>This group will receive 12 g of corn starch as a control group.</description>
      <arm_group_label>Placebo Group</arm_group_label>
      <other_name>Placebo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female sex&#xD;
  &#xD;
            -  Age 18 to 65 years&#xD;
  &#xD;
            -  Polycystic Ovary Syndrome diagnosed by specialist&#xD;
  &#xD;
            -  Useful enteral feeding&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Diabetes mellitus&#xD;
  &#xD;
            -  Risk of intestinal perforation&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Luis B Enríquez-Sánchez</last_name>
      <role>Study Director</role>
      <affiliation>Universidad Autonoma de Chihuahua</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carolina Martinez Loya</last_name>
      <phone>6143543923</phone>
      <phone_ext>+52</phone_ext>
      <email>caromtzloya@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ruth Favela Ortiz</last_name>
      <phone>6142277559</phone>
      <phone_ext>+52</phone_ext>
      <email>rfavelaortiz@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Central del Estado de Chihuahua</name>
        <address>
          <city>Chihuahua</city>
          <zip>31000</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Carolina Martínez Loya, M.D.</last_name>
        <phone>+526143543923</phone>
        <email>caromtzloya@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ruth S Favela Ortiz</last_name>
        <phone>6142277559</phone>
        <phone_ext>+52</phone_ext>
        <email>rfavelaortiz@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Autonoma de Chihuahua</investigator_affiliation>
      <investigator_full_name>Carolina Martínez Loya, MD</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>Polycystic Ovary Syndrome</keyword>
    <keyword>Prebiotics</keyword>
    <keyword>Enteral Diet</keyword>
    <keyword>Clinical Manifestations</keyword>
    <keyword>SC-FOS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data obtained from this research study will be available if requested once the study is finalized.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>The data will be available for up to five years since completion of the study.</ipd_time_frame>
      <ipd_access_criteria>The request for the data will be by e-mail</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999097
  org study id: 030C-06/23
  nct id: NCT05999097
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine if there is a difference in the clinical
        characteristics of patients with polycystic ovary syndrome after the administration of SC-FOS
        in the enteral diet compared to patients with a standard diet.
  The protocol will be discussed with the patients and/or relatives of the patients, who will
        understand the consequences and advantages of the study and will thus sign the consent.
  
        Once informed consent has been obtained, the group to which each patient belongs will be
        randomly assigned.
  
        Patients will be selected according to the inclusion and exclusion criteria of the population
        diagnosed with PCOS with useful enteral route for random assignment into two groups, one will
        be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours, another
        group will be given saline as a placebo to the enteral diet every 24 hours for 10 days.
        Patients should take the solution on an empty stomach.
  
        Once the type of intervention has been determined, the patient will be given the suspensions
        corresponding to group 1 or placebo, with vials in which the content cannot be visualized,
        numbered according to the sheet obtained by the corresponding randomization. The initial
        evaluation will be completed with all the clinical characteristics to be evaluated.
  
        The patient will be told that every 24 hours he must take 1 suspension on an empty stomach,
        which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the
        prebiotic preparation vs 15 cc of saline solution for the placebo group. The solution will be
        administered enterally for 10 consecutive days at a single dose per day, and a reassessment
        will be made on the seventh day of the clinical characteristics of the patients, to compare
        and evaluate the results.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective study, randomized single blind clinical trial
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Single (Participant)
  measure: Score of Bristol Scale
  time frame: 10 days
  description: Score obtained by Stool Consistency Bristol Scale:
  This scale consist in seven types of stool:
  Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)
  measure: Score Short Form Health Survey (SF-36)
  time frame: 10 days
  description: Short Form Health Survey (SF-36) is a measure of health-related quality-of-life:
  It comprises 36 questions that cover eight domains of health
  Limitations in physical activities because of health problems.
  Limitations in social activities because of physical or emotional problems
  Limitations in usual role activities because of physical health problems
  Bodily pain
  General mental health (psychological distress and well-being)
  Limitations in usual role activities because of emotional problems
  Vitality (energy and fatigue)
  General health perceptions
  arm group label: Short Chain Fructooligosaccharides Group
  arm group type: Experimental
  description: This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml
  arm group label: Placebo Group
  arm group type: Placebo Comparator
  description: This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml
  intervention type: Dietary Supplement
  intervention name: Short Chain Fructooligosaccharides
  description: The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.
  arm group label: Short Chain Fructooligosaccharides Group
  other name: Prebiotics
  intervention type: Dietary Supplement
  intervention name: Placebo Group
  description: This group will receive 12 g of corn starch as a control group.
  arm group label: Placebo Group
  other name: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Luis B Enríquez-Sánchez
  role: Study Director
  affiliation: Universidad Autonoma de Chihuahua
  last name: Carolina Martinez Loya
  phone: 6143543923
  phone ext: +52
  email: caromtzloya@gmail.com
  last name: Ruth Favela Ortiz
  phone: 6142277559
  phone ext: +52
  email: rfavelaortiz@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Mexico
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Autonoma de Chihuahua
  investigator full name: Carolina Martínez Loya, MD
  investigator title: Medical Doctor
  mesh term: Polycystic Ovary Syndrome
  mesh term: Syndrome
  sharing ipd: Yes
  ipd description: The data obtained from this research study will be available if requested once the study is finalized.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: The data will be available for up to five years since completion of the study.
  ipd access criteria: The request for the data will be by e-mail