<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/NCT02984969</url>
  </required_header>
  <id_info>
    <org_study_id>STC-2016-16sRNA</org_study_id>
    <nct_id>NCT02984969</nct_id>
  </id_info>
  <brief_title>Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients</brief_title>
  <official_title>Characterization of Intestinal Microbiota in Constipation Patients: Using 16S rRNA Gene Sequencing Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms&#xD;
      and thus has several clinical definitions. According to the Rome III criteria for chronic&#xD;
      constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it&#xD;
      is more prevalent and symptomatic in women and elderly people. Slow transit constipation&#xD;
      (STC) is the major category and is characterized by a decreased rate of colonic transit.&#xD;
&#xD;
      Recently, many researchers have focused on the relationship between intestinal microbiota and&#xD;
      constipation and have demonstrated that intestinal microbiota contribute to the&#xD;
      pathophysiology of functional gastrointestinal disorders.&#xD;
&#xD;
      Thus, there is a need for an improved understanding of gut microbiota composition in&#xD;
      constipation patients and for the potential role played by the gut microbiota in the etiology&#xD;
      of STC.To achieve this goal the investigators characterized and compared the intestinal&#xD;
      microbiota among carefully selected patients with constipation that were clinically&#xD;
      categorized based on Rome III criteria, and healthy controls using high throughput&#xD;
      pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative&#xD;
      changes in the relative abundances of taxa.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fecal microbiota sequence</measure>
    <time_frame>Within a week after enroll</time_frame>
    <description>The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods at BGI-Shenzhen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stool short-chain fatty acids (SCFAs)</measure>
    <time_frame>Within a week after enroll</time_frame>
    <description>The stool short-chain fatty acids (SCFAs) were extracted and quantitatively analysed by gas chromatography-mass spectrometry (GC-MS)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Slow Transit Constipation</condition>
  <arm_group>
    <arm_group_label>Slow transit constipation</arm_group_label>
    <description>subjects met the Rome III criteria for STC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Healthy controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 18 subjects met the Rome III criteria for STC and 17 healthy controls were&#xD;
        recruit from Jinling Hospital, a teaching hospital of Nanjing University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic constipation according to Rome III criteria, defined as two or fewer&#xD;
             spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;&#xD;
&#xD;
          2. Age &gt; 18 years;&#xD;
&#xD;
          3. BMI: 18.5-25 kg/m2;&#xD;
&#xD;
          4. Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) &gt;&#xD;
             48 hours);&#xD;
&#xD;
          5. Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to&#xD;
             expel rectal balloon;&#xD;
&#xD;
          6. No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical&#xD;
             (i.e. significant rectocele and intussusception) impediment to the expulsion of the&#xD;
             radio-opaque contrast;&#xD;
&#xD;
          7. Disease duration &gt; 1 year;&#xD;
&#xD;
          8. Traditional treatment with dietary modification, laxatives (including osmotic and&#xD;
             stimulant laxatives), and biofeedback tried over the past 6 months without success;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions&#xD;
             (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);&#xD;
&#xD;
          2. History or evidence of gastrointestinal diseases (i.e. obstruction, cancer,&#xD;
             inflammatory bowel diseases) ;&#xD;
&#xD;
          3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and&#xD;
             cesarean section;&#xD;
&#xD;
          4. Previous proctological or perianal surgery;&#xD;
&#xD;
          5. A constipation condition meeting the Rome III criteria for IBS or functional abdominal&#xD;
             pain syndrome;&#xD;
&#xD;
          6. Pregnant or breast-feeding women;&#xD;
&#xD;
          7. Infection with enteric pathogen;&#xD;
&#xD;
          8. Usage of probiotics, prebiotics and/or synbiotics within the last month;&#xD;
&#xD;
          9. Usage of antibiotics and/or PPIs within the last 3 months;&#xD;
&#xD;
         10. Smoking or alcohol addiction within the last 3 months;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hongliang Tian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianfeng Gong, PhD</last_name>
    <phone>+86-25-80860036</phone>
    <email>jinlingh_gongjf@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ning Li</last_name>
    <phone>+86-25-80860089</phone>
    <email>jinlingh_lining@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianfeng Gong, MD</last_name>
      <phone>+86-25-80860036</phone>
      <email>gongjianfeng@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Gong</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02984969
org study id: STC-2016-16sRNA
nct id: NCT02984969
lead sponsor: 
has dmc: Yes
Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms
      and thus has several clinical definitions. According to the Rome III criteria for chronic
      constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it
      is more prevalent and symptomatic in women and elderly people. Slow transit constipation
      (STC) is the major category and is characterized by a decreased rate of colonic transit.

      Recently, many researchers have focused on the relationship between intestinal microbiota and
      constipation and have demonstrated that intestinal microbiota contribute to the
      pathophysiology of functional gastrointestinal disorders.

      Thus, there is a need for an improved understanding of gut microbiota composition in
      constipation patients and for the potential role played by the gut microbiota in the etiology
      of STC.To achieve this goal the investigators characterized and compared the intestinal
      microbiota among carefully selected patients with constipation that were clinically
      categorized based on Rome III criteria, and healthy controls using high throughput
      pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative
      changes in the relative abundances of taxa.
observational model: Cohort
time perspective: Prospective
measure: Fecal microbiota sequence
time frame: Within a week after enroll
description: The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods at BGI-Shenzhen
measure: Stool short-chain fatty acids (SCFAs)
time frame: Within a week after enroll
description: The stool short-chain fatty acids (SCFAs) were extracted and quantitatively analysed by gas chromatography-mass spectrometry (GC-MS)
arm group label: Slow transit constipation
description: subjects met the Rome III criteria for STC
arm group label: Healthy subjects
description: Healthy controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hongliang Tian
role: Principal Investigator
affiliation: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
last name: Jianfeng Gong, PhD
phone: +86-25-80860036
email: jinlingh_gongjf@126.com
last name: Ning Li
phone: +86-25-80860089
email: jinlingh_lining@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Jianfeng Gong
investigator title: PhD
mesh term: Constipation
sharing ipd: Undecided