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Early Nutrition in Acute Pancreatitis (OZT)

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ClinicalTrials.gov Identifier: NCT03820128
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date January 29, 2019
Estimated Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
Length of hospitalization [ Time Frame: through study completion, an average of 2 years ]
Number days of hospitalization
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Time between the onset of symptoms and the first feeding [ Time Frame: assessed at the day of 2 ]
    Time between the onset of symptoms and the first feeding measured in hours
  • Adverse events [ Time Frame: daily assessment in the first three days of hospitalization ]
    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
  • Average calories intake [ Time Frame: through study completion, an average of 2 years ]
    Average calories intake (kcal)
  • Levels of proinflammatory cytokine levels. [ Time Frame: through study completion, an average of 2 years ]
    Proinflammatory cytokine levels (ng/ml) using ELISA tests
  • Zonulin level [ Time Frame: through study completion, an average of 2 years ]
    Zonulin level (ng/ml) using ELISA test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Nutrition in Acute Pancreatitis
Official Title  ICMJE Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Pancreatitis
Intervention  ICMJE Other: Early diet intervention
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.
Study Arms  ICMJE
  • Active Comparator: Very early refeeding

    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.

    Intervention: Other: Early diet intervention
  • Active Comparator: Early refeeding

    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: Other: Early diet intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:

    • Abdominal pain of pancreatic origin
    • Radiologic findings supportive of AP on imaging
    • Amylase or lipase levels elevation three times above the upper limit of normal
  • Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
  • No contradictions to enteral treatment
  • Informed consent from the parents or legal guardian and from the patient if older than 16 years

Exclusion Criteria:

  • Severe general condition
  • Severe AP
  • Kidney insufficiency, cardiac insufficiency
  • Diabetes type 1
  • Cystic fibrosis
  • Contraindications to enteral feeding
  • Lack of required informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aleksandra Banaszkiewicz, Ass. Prof. 48 22 317 9451 abanaszkiewicz@wum.edu.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820128
Other Study ID Numbers  ICMJE OZT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Warsaw
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP