<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/NCT02254629</url>
  </required_header>
  <id_info>
    <org_study_id>2014SDU-QILU-G04</org_study_id>
    <nct_id>NCT02254629</nct_id>
  </id_info>
  <brief_title>The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients</brief_title>
  <official_title>The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the&#xD;
      fecal microbiota of the patients in a more robust manner .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert&#xD;
      therapeutic effects on IBS patients. The laxatives could also alter the gut microflora&#xD;
      significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and&#xD;
      the composition of fecal microbiota in the IBS patients in a more robust manner .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject's Global Assessment of Relief</measure>
    <time_frame>8 months</time_frame>
    <description>The SGA (subjective global assessment) of Relief was assessed by answering the following question: &quot;Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week?&quot; The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The changes of symptom scores</measure>
    <time_frame>8 months</time_frame>
    <description>The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBS patients'quality of life</measure>
    <time_frame>8 months</time_frame>
    <description>Quality of life was determined by using IBS-QOL scoring system for patients with IBS. This questionnaire comprises a range of 34 items with response options on a 5-point rating scale. The items contribute to 8 domains as follows: Dysphoria, Interference with activity, Body image, Health worry, Food avoidance, Social reaction, Sexual, Relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composition of Microorganisms in stool</measure>
    <time_frame>8 months</time_frame>
    <description>Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>laxative-probiotic sequential</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>probiotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laxative followed by Probiotic 2 weeks later</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotic Clostridium Butyricum</intervention_name>
    <description>probiotic:2 tablets/ times, 3 times / day for 2 weeks</description>
    <arm_group_label>Laxative followed by Probiotic 2 weeks later</arm_group_label>
    <arm_group_label>laxative-probiotic sequential</arm_group_label>
    <arm_group_label>probiotic</arm_group_label>
    <other_name>Clostridium Butyricum Tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Laxative Polyethylene Glycol</intervention_name>
    <description>laxative：2000 ml.</description>
    <arm_group_label>Laxative followed by Probiotic 2 weeks later</arm_group_label>
    <arm_group_label>laxative-probiotic sequential</arm_group_label>
    <other_name>Polyethylene Glycol Electrolytes Powder.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of Rome III criteria for IBS ;&#xD;
&#xD;
          -  Patients scheduled for colonoscopy examination or having negative screening&#xD;
             examinations&#xD;
&#xD;
          -  Aged between 18 and 65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antibiotic, probiotic or laxative usage within 4 weeks.&#xD;
&#xD;
          -  organic gastrointestinal diseases&#xD;
&#xD;
          -  Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction,&#xD;
             thyroid disease or tumor etc.&#xD;
&#xD;
          -  pregnancy or lactation.&#xD;
&#xD;
          -  previous major or complicated abdominal surgery.&#xD;
&#xD;
          -  severe endometriosis and dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqing Li, MD.PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yanqing Li, MD.PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>August 30, 2016</last_update_submitted>
  <last_update_submitted_qc>August 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Vice president of Qilu Hospital</investigator_title>
  </responsible_party>
  <keyword>Fecal microflora</keyword>
  <keyword>IBS</keyword>
  <keyword>Sequential treatment</keyword>
  <keyword>Probiotic</keyword>
  <keyword>Laxative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Laxatives</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02254629
org study id: 2014SDU-QILU-G04
nct id: NCT02254629
lead sponsor: 
has dmc: Yes
the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the
      fecal microbiota of the patients in a more robust manner .
Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert
      therapeutic effects on IBS patients. The laxatives could also alter the gut microflora
      significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and
      the composition of fecal microbiota in the IBS patients in a more robust manner .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Subject's Global Assessment of Relief
time frame: 8 months
description: The SGA (subjective global assessment) of Relief was assessed by answering the following question: "Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week?" The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse.
measure: The changes of symptom scores
time frame: 8 months
description: The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining.
measure: IBS patients'quality of life
time frame: 8 months
description: Quality of life was determined by using IBS-QOL scoring system for patients with IBS. This questionnaire comprises a range of 34 items with response options on a 5-point rating scale. The items contribute to 8 domains as follows: Dysphoria, Interference with activity, Body image, Health worry, Food avoidance, Social reaction, Sexual, Relationship.
measure: Composition of Microorganisms in stool
time frame: 8 months
description: Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
arm group label: laxative-probiotic sequential
arm group type: Experimental
description: laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
arm group label: probiotic
arm group type: Active Comparator
description: Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.
arm group label: Laxative followed by Probiotic 2 weeks later
arm group type: Active Comparator
description: laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.
intervention type: Drug
intervention name: Probiotic Clostridium Butyricum
description: probiotic:2 tablets/ times, 3 times / day for 2 weeks
arm group label: Laxative followed by Probiotic 2 weeks later
arm group label: laxative-probiotic sequential
arm group label: probiotic
other name: Clostridium Butyricum Tablets
intervention type: Drug
intervention name: Laxative Polyethylene Glycol
description: laxative：2000 ml.
arm group label: Laxative followed by Probiotic 2 weeks later
arm group label: laxative-probiotic sequential
other name: Polyethylene Glycol Electrolytes Powder.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yanqing Li, MD.PhD
role: Principal Investigator
affiliation: Qilu Hospital, Shandong University
last name: Yanqing Li, MD.PhD.
role: Principal Investigator
affiliation: Qilu Hospital, Shandong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Vice president of Qilu Hospital
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Laxatives