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/NCT06001060</url>
    </required_header>
    <id_info>
      <org_study_id>2023004</org_study_id>
      <nct_id>NCT06001060</nct_id>
    </id_info>
    <brief_title>Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.</brief_title>
    <official_title>1. Study Design 2. Sample Collection 3. Microbial DNA Extraction in Faecal Samples 4. PCR Amplification： 5. Sequencing： 6. HCY Test Principle: 7. Statistical Analysis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First People's Hospital of Hangzhou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First People's Hospital of Hangzhou</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>
        The goal of this observational study is to test the alterations of gut microbiota composition&#xD;
        among women of reproductive age with elevated homocysteine levels. The main question it aims&#xD;
        to answer is:&#xD;
  &#xD;
        • the relationship between gut microbiota composition and recurrent abortion. Participants&#xD;
        will provide their stool samples to be detected the composition of gut microbiota. .&#xD;
  &#xD;
        Researchers will compare women of reproductive age with normal homocysteine levels to see if&#xD;
        any bacteria were involved in recurrent miscarriages.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 20, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>homocysteine levels</measure>
      <time_frame>The first day of the trail</time_frame>
      <description>Binding or dimer homocysteine (oxidized form) is reduced to free homocysteine, and then it is catalysed by cysteine β-synthetase (CBS) to react with serine to form cysteine sulfuric acid. Cysteine is then broken down by cysteine β-lyase (CBL) to form homocysteine, pyruvate, and ammonia. Pyruvate is then converted to lactate using lactate dehydrogenase (LDH), where nicotinamide adenine dinucleotide (NADH) is used as a coenzyme. The ratio of NADH to NAD* is directly proportional to the concentration of homocysteine (△ A340 nm).</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">38</enrollment>
    <condition>Recurrent Miscarriage</condition>
    <arm_group>
      <arm_group_label>women of reproductive age with elevated homocysteine levels</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          patients or healthy individuals who visited Hangzhou First People's Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  No recent antibiotic treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recently received antibiotics&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Hangzhou First People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Abortion, Spontaneous</mesh_term>
      <mesh_term>Abortion, Habitual</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </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/NCT06001060
  org study id: 2023004
  nct id: NCT06001060
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to test the alterations of gut microbiota composition
        among women of reproductive age with elevated homocysteine levels. The main question it aims
        to answer is:
  
        • the relationship between gut microbiota composition and recurrent abortion. Participants
        will provide their stool samples to be detected the composition of gut microbiota. .
  
        Researchers will compare women of reproductive age with normal homocysteine levels to see if
        any bacteria were involved in recurrent miscarriages.
  observational model: Cohort
  time perspective: Retrospective
  measure: homocysteine levels
  time frame: The first day of the trail
  description: Binding or dimer homocysteine (oxidized form) is reduced to free homocysteine, and then it is catalysed by cysteine β-synthetase (CBS) to react with serine to form cysteine sulfuric acid. Cysteine is then broken down by cysteine β-lyase (CBL) to form homocysteine, pyruvate, and ammonia. Pyruvate is then converted to lactate using lactate dehydrogenase (LDH), where nicotinamide adenine dinucleotide (NADH) is used as a coenzyme. The ratio of NADH to NAD* is directly proportional to the concentration of homocysteine (△ A340 nm).
  arm group label: women of reproductive age with elevated homocysteine levels
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 35 Years
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Abortion, Spontaneous
  mesh term: Abortion, Habitual
  sharing ipd: Yes