Early Nutrition in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— OZT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03820128
• Other study ID #: OZT
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: June 2018
• Source: Medical University of Warsaw
• Contact: Aleksandra Banaszkiewicz, Ass. Prof.
• Phone: 48 22 317 9451
• Email: abanaszkiewicz[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: January 31, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
Poland	Departement of Paediatric Gastroenterology and Nutrition.	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization	Number days of hospitalization	through study completion, an average of 2 years
Secondary	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
Secondary	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
Secondary	Average calories intake	Average calories intake (kcal)	through study completion, an average of 2 years
Secondary	Levels of proinflammatory cytokine levels.	Proinflammatory cytokine levels (ng/ml) using ELISA tests	through study completion, an average of 2 years
Secondary	Zonulin level	Zonulin level (ng/ml) using ELISA test	through study completion, an average of 2 years