NCT03820128

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

January 29, 2019

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

June 14, 2018

Last Update Submit

January 25, 2019

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Length of hospitalization

    Number days of hospitalization

    through study completion, an average of 2 years

Secondary Outcomes (5)

  • Time between the onset of symptoms and the first feeding

    assessed at the day of 2

  • Adverse events

    daily assessment in the first three days of hospitalization

  • Average calories intake

    through study completion, an average of 2 years

  • Levels of proinflammatory cytokine levels.

    through study completion, an average of 2 years

  • Zonulin level

    through study completion, an average of 2 years

Study Arms (2)

Very early refeeding

ACTIVE COMPARATOR

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

Early refeeding

ACTIVE COMPARATOR

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

Interventions

Early diet interventionOTHER

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 refeedingVery early refeeding

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Severe general condition
  • Severe AP
  • Kidney insufficiency, cardiac insufficiency
  • Diabetes type 1
  • Cystic fibrosis
  • Contraindications to enteral feeding
  • Lack of required informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Paediatric Gastroenterology and Nutrition.

Warsaw, 02-091, Poland

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Aleksandra Banaszkiewicz, Ass. Prof.

CONTACT

48 22 317 9451abanaszkiewicz@wum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2018

First Posted

January 29, 2019

Study Start

February 1, 2019

Primary Completion

October 1, 2020

Study Completion

January 31, 2021

Last Updated

January 29, 2019

Record last verified: 2018-06

Locations

PL(1)