<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/NCT02233062</url>
  </required_header>
  <id_info>
    <org_study_id>20140901</org_study_id>
    <secondary_id>NSFC</secondary_id>
    <nct_id>NCT02233062</nct_id>
  </id_info>
  <brief_title>Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease</brief_title>
  <official_title>Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm&#xD;
      quality of patients with crohn's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The highest age- and sex-adjusted incidence rates for Crohn's Disease (CD) occur during the&#xD;
      peak reproductive years. In addition, gastroenterologists frequently advise and manage&#xD;
      patients with CD who desire to conceive. Enteral nutrition therapy is effective for induction&#xD;
      and maintenance of remission in reproductive age men with CD. However, there is no available&#xD;
      data on the effects of enteral nutrition therapy on semen quality. The purpose of this study&#xD;
      is to investigate the impact of enteral nutrition therapy on sperm quality of patients with&#xD;
      CD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sperm motility</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Sperm motility is a useful marker of sperm quality. The normal level of sperm motility (World Health Organization criteria) should be higher than 50%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Crohn's Disease Activity Index</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Semen quality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Exclusive Enteral Nutrition Therapy</intervention_name>
    <arm_group_label>Semen quality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Crohn' Disease&#xD;
&#xD;
          -  Male patients&#xD;
&#xD;
          -  Age: 18-40 years old&#xD;
&#xD;
          -  Receive 3-months exclusive enteral nutrition therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Used any experimental therapy in the 8 weeks before study entry date&#xD;
&#xD;
          -  Had previously documented problems with male reproductive health, such as low sperm&#xD;
             count, impotence, or malignancy&#xD;
&#xD;
          -  The use of concomitant medication including sulphasalazine, 5-aminosalicylic acid or&#xD;
             other immune-suppressives.&#xD;
&#xD;
          -  Unable to complete the 3-months exclusive enteral nutrition therapy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of General Surgery, Jinling Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Jianan Ren</investigator_full_name>
    <investigator_title>Vice president</investigator_title>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>semen quality</keyword>
  <keyword>enteral nutrition</keyword>
  <keyword>CDAI score higher than 150</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_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/NCT02233062
org study id: 20140901
secondary id: NSFC
nct id: NCT02233062
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm
      quality of patients with crohn's disease.
The highest age- and sex-adjusted incidence rates for Crohn's Disease (CD) occur during the
      peak reproductive years. In addition, gastroenterologists frequently advise and manage
      patients with CD who desire to conceive. Enteral nutrition therapy is effective for induction
      and maintenance of remission in reproductive age men with CD. However, there is no available
      data on the effects of enteral nutrition therapy on semen quality. The purpose of this study
      is to investigate the impact of enteral nutrition therapy on sperm quality of patients with
      CD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sperm motility
time frame: Up to 3 months
description: Sperm motility is a useful marker of sperm quality. The normal level of sperm motility (World Health Organization criteria) should be higher than 50%.
measure: Crohn's Disease Activity Index
time frame: Up to 3 months
arm group label: Semen quality
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Exclusive Enteral Nutrition Therapy
arm group label: Semen quality
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Jianan Ren
investigator title: Vice president
mesh term: Crohn Disease