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/NCT05997745</url>
    </required_header>
    <id_info>
      <org_study_id>002</org_study_id>
      <nct_id>NCT05997745</nct_id>
    </id_info>
    <brief_title>Enteral Nutrition in Acute Generalized Peritonitis</brief_title>
    <acronym>PAG/NUTRI</acronym>
    <official_title>Effects of Early Enteral Nutrition With a Locally Produced Protein-energy Ration Versus a Marketed Nutritional Solution in Patients Operated on for Acute Generalized Peritonitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université Evangélique enAfrique</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Université Evangélique enAfrique</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>
        Hospitals in South Kivu always have problems supplying artificial enteral nutritional&#xD;
        products because of their high cost and low availability in our areas. While the Province has&#xD;
        cereals, knowing their nutritional composition would enable the formulation of a nutritional&#xD;
        product based on local protein-energy products. Hence the questions below: Can a local&#xD;
        cereal-based protein-energy ration be used instead of a costly imported artificial&#xD;
        nutritional solution to improve the nutritional status of patients operated on for PAG? What&#xD;
        is the tolerance of this early enteral nutrition on the healing and functional recovery of&#xD;
        patients compared with an artificial nutritional solution? To answer these questions, a&#xD;
        randomized clinical trial has been designed with the following objectives:&#xD;
  &#xD;
          -  To formulate an enteral diet using cereals available in our environment with a&#xD;
             protein-calorie composition superimposable on the artificial enteral ration,&#xD;
  &#xD;
          -  Evaluate the tolerance and advantages of early enteral nutrition with a locally&#xD;
             manufactured protein-caloric ration vs. a commercially available artificial nutritional&#xD;
             solution in patients undergoing surgery for PAG.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Tolerability of feeding</measure>
      <time_frame>10 days after surgery</time_frame>
      <description>We will screen complications after feeding</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>nutritional surveillance</measure>
      <time_frame>2 days after, 5 days after, 10 days after feeding</time_frame>
      <description>changes in nutritional status using body mass index, albumin measurement, anthropometric data</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Enteral and Supplement Feeds Adverse Reaction</condition>
    <condition>Peritonitis; Acute</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>study group</intervention_name>
      <description>Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patient operated for peritonitis with intestinal suture during treatment&#xD;
  &#xD;
            -  have a q-SOFA score of 1 to 2&#xD;
  &#xD;
            -  surgeon's agreement to enteral feeding&#xD;
  &#xD;
            -  at risk of malnutrition (BMC)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  q SOFA score &gt; 2&#xD;
  &#xD;
            -  patients with tare (diabetes, HIV, renal failure)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>JEAN PAUL CIKWANINE, MASTER</last_name>
      <phone>+243990860491</phone>
      <email>jpcikwa1@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>Peritonitis</mesh_term>
    </condition_browse>
    <!-- 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/NCT05997745
  org study id: 002
  nct id: NCT05997745
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Hospitals in South Kivu always have problems supplying artificial enteral nutritional
        products because of their high cost and low availability in our areas. While the Province has
        cereals, knowing their nutritional composition would enable the formulation of a nutritional
        product based on local protein-energy products. Hence the questions below: Can a local
        cereal-based protein-energy ration be used instead of a costly imported artificial
        nutritional solution to improve the nutritional status of patients operated on for PAG? What
        is the tolerance of this early enteral nutrition on the healing and functional recovery of
        patients compared with an artificial nutritional solution? To answer these questions, a
        randomized clinical trial has been designed with the following objectives:
  
          -  To formulate an enteral diet using cereals available in our environment with a
             protein-calorie composition superimposable on the artificial enteral ration,
  
          -  Evaluate the tolerance and advantages of early enteral nutrition with a locally
             manufactured protein-caloric ration vs. a commercially available artificial nutritional
             solution in patients undergoing surgery for PAG.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Tolerability of feeding
  time frame: 10 days after surgery
  description: We will screen complications after feeding
  measure: nutritional surveillance
  time frame: 2 days after, 5 days after, 10 days after feeding
  description: changes in nutritional status using body mass index, albumin measurement, anthropometric data
  arm group label: study group
  arm group type: Experimental
  description: an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis
  arm group label: control group
  arm group type: Active Comparator
  description: patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis
  intervention type: Dietary Supplement
  intervention name: study group
  description: Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis
  arm group label: control group
  arm group label: study group
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: N/A
  healthy volunteers: No
  last name: JEAN PAUL CIKWANINE, MASTER
  phone: +243990860491
  email: jpcikwa1@gmail.com
  responsible party type: Sponsor
  mesh term: Peritonitis