Early Nutrition in Acute Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Other: Early diet intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Very early refeeding<br>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. | Other: Early diet intervention<br>* 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.<br>|
| Active Comparator: Early refeeding<br>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. | Other: Early diet intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | Number days of hospitalization | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between the onset of symptoms and the first feeding | Time between the onset of symptoms and the first feeding measured in hours | assessed at the day of 2 | 
| 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 | daily assessment in the first three days of hospitalization | 
| Average calories intake | Average calories intake (kcal) | through study completion, an average of 2 years | 
| Levels of proinflammatory cytokine levels. | Proinflammatory cytokine levels (ng/ml) using ELISA tests | through study completion, an average of 2 years | 
| Zonulin level | Zonulin level (ng/ml) using ELISA test | through study completion, an average of 2 years |