Trials / Unknown
UnknownNCT03820128
Early Nutrition in Acute Pancreatitis
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- Medical University of Warsaw · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2020-10-01
- Completion
- 2021-01-31
- First posted
- 2019-01-29
- Last updated
- 2019-01-29
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT03820128. Inclusion in this directory is not an endorsement.