Early Nutrition in Acute Pancreatitis (OZT)

• ClinicalTrials.gov Identifier: NCT03820128
• Recruitment Status: Not yet recruiting
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Sponsor: Medical University of Warsaw
• Information provided by (Responsible Party): Medical University of Warsaw

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.

Condition or disease	Intervention/treatment	Phase
Acute Pancreatitis	Other: Early diet intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
• Estimated Study Start Date: February 1, 2019
• Estimated Primary Completion Date: October 1, 2020
• Estimated Study Completion Date: January 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Length of hospitalization [ Time Frame: through study completion, an average of 2 years ]
   Number days of hospitalization

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Aleksandra Banaszkiewicz, Ass. Prof.; 48 22 317 9451; abanaszkiewicz@wum.edu.pl

Locations

Poland

Departement of Paediatric Gastroenterology and Nutrition.

Warsaw, Poland, 02-091

Sponsors and Collaborators

Medical University of Warsaw

More Information

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT03820128
• Other Study ID Numbers: OZT
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Last Verified: June 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatitis; Pancreatic Diseases; Digestive System Diseases