Early Nutrition in Acute Pancreatitis

Not Applicable

• Conditions: Acute Pancreatitis
• Interventions: Other: Early diet intervention

• Registration Number: NCT03820128
• Lead Sponsor: Medical University of Warsaw

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 Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Study First Posted: 2019-01-29
• Last Update Posted: 2019-01-29
• Study Start: 2019-02-01
• Primary Completion: 2020-10-01
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early refeeding	Early diet intervention	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.
Very early refeeding	Early diet intervention	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.

Primary Outcome Measures

Name	Time	Method
Length of hospitalization	through study completion, an average of 2 years	Number days of hospitalization

Secondary Outcome Measures

Name	Time	Method
Levels of proinflammatory cytokine levels.	through study completion, an average of 2 years	Proinflammatory cytokine levels (ng/ml) using ELISA tests
Zonulin level	through study completion, an average of 2 years	Zonulin level (ng/ml) using ELISA test
Time between the onset of symptoms and the first feeding	assessed at the day of 2	Time between the onset of symptoms and the first feeding measured in hours
Average calories intake	through study completion, an average of 2 years	Average calories intake (kcal)
Adverse events	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

Trial Locations

Locations (1)

Departement of Paediatric Gastroenterology and Nutrition.; 🇵🇱 Warsaw, Poland