<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/NCT03820128</url>
  </required_header>
  <id_info>
    <org_study_id>OZT</org_study_id>
    <nct_id>NCT03820128</nct_id>
  </id_info>
  <brief_title>Early Nutrition in Acute Pancreatitis</brief_title>
  <acronym>OZT</acronym>
  <official_title>Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the effect of the early oral refeeding and fat content in&#xD;
      the diet on the length of stay, clinical course (included pain severity) in pediatric&#xD;
      patients with mild and moderate AP. Patients will be randomized to groups: refeeding within&#xD;
      24 hours or after 24 hours from the hospital admission. Biochemical tests and pain severity&#xD;
      will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, randomized study. Research in the adult population shows that early enteral&#xD;
      feeding in acute pancreatitis (AP) both oral and via the feeding tube is safe, shortens the&#xD;
      length of hospital stay, prevents the multi organ failure (MoF) and reduces mortality. The&#xD;
      pediatric population lacks prospective data concerning refeeding modes in AP. The aim of the&#xD;
      study is to assess the effect of the early oral refeeding and fat content in the diet on the&#xD;
      length of stay, clinical course (included pain severity) in pediatric patients with mild and&#xD;
      moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24&#xD;
      hours from the hospital admission. Biochemical tests including CRP, amylase, lipase and&#xD;
      proinflammatory cytokines levels and zonulin level as well as severity of pain will be&#xD;
      assessed again in the second, the third and the fifth hospital day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Number days of hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time between the onset of symptoms and the first feeding</measure>
    <time_frame>assessed at the day of 2</time_frame>
    <description>Time between the onset of symptoms and the first feeding measured in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>daily assessment in the first three days of hospitalization</time_frame>
    <description>Severity of abdominal pain daily using a 10 point visual - analog scale (VAS). 0 means lack of the pain, 10 means the most severe pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average calories intake</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Average calories intake (kcal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of proinflammatory cytokine levels.</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Proinflammatory cytokine levels (ng/ml) using ELISA tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zonulin level</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Zonulin level (ng/ml) using ELISA test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Very early refeeding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Very early diet intervention: refeeding within 24 hours from the hospital admission.&#xD;
Participants will be encouraged to start eating immediately after the time of admission. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early refeeding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Early diet intervention: refeeding after 24 hours from the hospital admission .&#xD;
During the first 24 hours after admission participants will be on fluid only (orally and/or intravenously). Later on they will be encouraged to start eating. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early diet intervention</intervention_name>
    <description>Participant's diet includes several low-fiber and low-fat commonly available meals and products. Patients will choose what they want to eat with no amount or calories restriction.</description>
    <arm_group_label>Early refeeding</arm_group_label>
    <arm_group_label>Very early refeeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AP diagnosis according to the generally accepted criteria ie. fulfilling two out of&#xD;
             three criteria:&#xD;
&#xD;
               -  Abdominal pain of pancreatic origin&#xD;
&#xD;
               -  Radiologic findings supportive of AP on imaging&#xD;
&#xD;
               -  Amylase or lipase levels elevation three times above the upper limit of normal&#xD;
&#xD;
          -  Mild or moderate AP Mild AP: AP without organ failure, local or general complications&#xD;
             Moderate AP: AP that may be accompanied by intermittent organ failure, local&#xD;
             complications or concomitant disease worsening&#xD;
&#xD;
          -  No contradictions to enteral treatment&#xD;
&#xD;
          -  Informed consent from the parents or legal guardian and from the patient if older than&#xD;
             16 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe general condition&#xD;
&#xD;
          -  Severe AP&#xD;
&#xD;
          -  Kidney insufficiency, cardiac insufficiency&#xD;
&#xD;
          -  Diabetes type 1&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Contraindications to enteral feeding&#xD;
&#xD;
          -  Lack of required informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Aleksandra Banaszkiewicz, Ass. Prof.</last_name>
    <phone>48 22 317 9451</phone>
    <email>abanaszkiewicz@wum.edu.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Departement of Paediatric Gastroenterology and Nutrition.</name>
      <address>
        <city>Warsaw</city>
        <zip>02-091</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>June 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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>Pancreatitis</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/NCT03820128
org study id: OZT
nct id: NCT03820128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the effect of the early oral refeeding and fat content in
      the diet on the length of stay, clinical course (included pain severity) in pediatric
      patients with mild and moderate AP. Patients will be randomized to groups: refeeding within
      24 hours or after 24 hours from the hospital admission. Biochemical tests and pain severity
      will be evaluated.
Prospective, randomized study. Research in the adult population shows that early enteral
      feeding in acute pancreatitis (AP) both oral and via the feeding tube is safe, shortens the
      length of hospital stay, prevents the multi organ failure (MoF) and reduces mortality. The
      pediatric population lacks prospective data concerning refeeding modes in AP. The aim of the
      study is to assess the effect of the early oral refeeding and fat content in the diet on the
      length of stay, clinical course (included pain severity) in pediatric patients with mild and
      moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24
      hours from the hospital admission. Biochemical tests including CRP, amylase, lipase and
      proinflammatory cytokines levels and zonulin level as well as severity of pain will be
      assessed again in the second, the third and the fifth hospital day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Length of hospitalization
time frame: through study completion, an average of 2 years
description: Number days of hospitalization
measure: Time between the onset of symptoms and the first feeding
time frame: assessed at the day of 2
description: Time between the onset of symptoms and the first feeding measured in hours
measure: Adverse events
time frame: daily assessment in the first three days of hospitalization
description: Severity of abdominal pain daily using a 10 point visual - analog scale (VAS). 0 means lack of the pain, 10 means the most severe pain
measure: Average calories intake
time frame: through study completion, an average of 2 years
description: Average calories intake (kcal)
measure: Levels of proinflammatory cytokine levels.
time frame: through study completion, an average of 2 years
description: Proinflammatory cytokine levels (ng/ml) using ELISA tests
measure: Zonulin level
time frame: through study completion, an average of 2 years
description: Zonulin level (ng/ml) using ELISA test
arm group label: Very early refeeding
arm group type: Active Comparator
description: Very early diet intervention: refeeding within 24 hours from the hospital admission.
Participants will be encouraged to start eating immediately after the time of admission. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge.
arm group label: Early refeeding
arm group type: Active Comparator
description: Early diet intervention: refeeding after 24 hours from the hospital admission .
During the first 24 hours after admission participants will be on fluid only (orally and/or intravenously). Later on they will be encouraged to start eating. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge.
intervention type: Other
intervention name: Early diet intervention
description: Participant's diet includes several low-fiber and low-fat commonly available meals and products. Patients will choose what they want to eat with no amount or calories restriction.
arm group label: Early refeeding
arm group label: Very early refeeding
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Aleksandra Banaszkiewicz, Ass. Prof.
phone: 48 22 317 9451
email: abanaszkiewicz@wum.edu.pl
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Pancreatitis