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Early Nutrition in Acute Pancreatitis (OZT)

Primary Purpose

Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Early diet intervention
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pancreatitis

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of Paediatric Gastroenterology and Nutrition.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Very early refeeding

Early refeeding

Arm 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.

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.

Outcomes

Primary Outcome Measures

Length of hospitalization
Number days of hospitalization

Secondary Outcome Measures

Time between the onset of symptoms and the first feeding
Time between the onset of symptoms and the first feeding measured in hours
Adverse events
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
Average calories intake (kcal)
Levels of proinflammatory cytokine levels.
Proinflammatory cytokine levels (ng/ml) using ELISA tests
Zonulin level
Zonulin level (ng/ml) using ELISA test

Full Information

First Posted
June 14, 2018
Last Updated
January 25, 2019
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03820128
Brief Title
Early Nutrition in Acute Pancreatitis
Acronym
OZT
Official Title
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very early refeeding
Arm Type
Active Comparator
Arm 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 Title
Early refeeding
Arm Type
Active Comparator
Arm 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(s)
Early diet intervention
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.
Primary Outcome Measure Information:
Title
Length of hospitalization
Description
Number days of hospitalization
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Time between the onset of symptoms and the first feeding
Description
Time between the onset of symptoms and the first feeding measured in hours
Time Frame
assessed at the day of 2
Title
Adverse events
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
Time Frame
daily assessment in the first three days of hospitalization
Title
Average calories intake
Description
Average calories intake (kcal)
Time Frame
through study completion, an average of 2 years
Title
Levels of proinflammatory cytokine levels.
Description
Proinflammatory cytokine levels (ng/ml) using ELISA tests
Time Frame
through study completion, an average of 2 years
Title
Zonulin level
Description
Zonulin level (ng/ml) using ELISA test
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Banaszkiewicz, Ass. Prof.
Phone
48 22 317 9451
Email
abanaszkiewicz@wum.edu.pl
Facility Information:
Facility Name
Departement of Paediatric Gastroenterology and Nutrition.
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland

12. IPD Sharing Statement

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Early Nutrition in Acute Pancreatitis

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