Acute Pancreatitis
Conditions
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.
Interventions
OTHEREarly 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.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | through study completion, an average of 2 years | Number days of hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Average calories intake | through study completion, an average of 2 years | Average calories intake (kcal) |
| 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 |
Countries
Poland
Contacts
Primary ContactAleksandra Banaszkiewicz, Ass. Prof.
Outcome results
None listed