Early Nutrition in Acute Pancreatitis

NCT ID: NCT03820128

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-01-31

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.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Early diet intervention

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Early diet intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Departement of Paediatric Gastroenterology and Nutrition.

Warsaw, , Poland

Countries

Poland

Central Contacts

Aleksandra Banaszkiewicz, Ass. Prof.

Role: CONTACT

abanaszkiewicz@wum.edu.pl

48 22 317 9451

Other Identifiers

OZT

Identifier Type: -

Identifier Source: org_study_id