<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/NCT04438473</url>
  </required_header>
  <id_info>
    <org_study_id>2019-112</org_study_id>
    <nct_id>NCT04438473</nct_id>
  </id_info>
  <brief_title>Pectin Supplemented Enteral Feedings in Critically Ill Patients</brief_title>
  <official_title>The Effect of Pectin Supplement on Enteral Nutrition-related Complications in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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 current study will enroll critically ill patients who are going to require enteral&#xD;
      nutrition support and randomize them to standard formula enteral nutrition or&#xD;
      pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related&#xD;
      complications will be recorded and compared between groups.&#xD;
&#xD;
      The study is trying to assess whether the use of pectin will improve the enteral&#xD;
      nutrition-related complications in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    discontinued prematurely by sponsor for strategic reasons&#xD;
  </why_stopped>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication of enteral feeding</measure>
    <time_frame>7 days</time_frame>
    <description>Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>feeding time of enteral nutrition</measure>
    <time_frame>7 days</time_frame>
    <description>Record daily feeding time of enteral nutrition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total energy intake</measure>
    <time_frame>7 days</time_frame>
    <description>Record daily energy intake</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Enteral Nutrition</condition>
  <condition>Dietary Fiber</condition>
  <arm_group>
    <arm_group_label>Pectin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>standard formula enteral nutrition feeding without pectin for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>pectin-supplemented enteral nutrition feeding</intervention_name>
    <description>sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days</description>
    <arm_group_label>Pectin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>enteral nutrition feeding</intervention_name>
    <description>standard formula enteral nutrition feeding without pectin for 7 days</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-80 years old, with informed consent to participate;&#xD;
&#xD;
          -  Critically ill patients who require enteral nutrition support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with lung infection at admission&#xD;
&#xD;
          -  Condition which contraindicates enteral feeding (i.e. intestinal obstruction)&#xD;
&#xD;
          -  Lack of enteral access&#xD;
&#xD;
          -  Any condition that would contraindicate use of the enteral nutrition&#xD;
&#xD;
          -  Require enteral nutrition support for less than 1week or more than 4 weeks from&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pianhong Zhang, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huzhou central hospital</name>
      <address>
        <city>Huzhou</city>
        <state>Zhejiang</state>
        <zip>313003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first hospital of Jiaxing</name>
      <address>
        <city>Jiaxing</city>
        <state>Zhejiang</state>
        <zip>314001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinhua municipal central hospital</name>
      <address>
        <city>Jinhua</city>
        <state>Zhejiang</state>
        <zip>321000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quzhou Kecheng People's Hospital</name>
      <address>
        <city>Quzhou</city>
        <state>Zhejiang</state>
        <zip>324000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <zip>317099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Wenzhou medical university</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</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>Critical Illness</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/NCT04438473
org study id: 2019-112
nct id: NCT04438473
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The current study will enroll critically ill patients who are going to require enteral
      nutrition support and randomize them to standard formula enteral nutrition or
      pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related
      complications will be recorded and compared between groups.

      The study is trying to assess whether the use of pectin will improve the enteral
      nutrition-related complications in critically ill patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Complication of enteral feeding
time frame: 7 days
description: Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying
measure: feeding time of enteral nutrition
time frame: 7 days
description: Record daily feeding time of enteral nutrition
measure: total energy intake
time frame: 7 days
description: Record daily energy intake
arm group label: Pectin
arm group type: Experimental
description: sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
arm group label: Control
arm group type: Placebo Comparator
description: standard formula enteral nutrition feeding without pectin for 7 days
intervention type: Dietary Supplement
intervention name: pectin-supplemented enteral nutrition feeding
description: sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
arm group label: Pectin
intervention type: Other
intervention name: enteral nutrition feeding
description: standard formula enteral nutrition feeding without pectin for 7 days
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pianhong Zhang, MS
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Critical Illness