Early Nutrition in Acute Pancreatitis (OZT)
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ClinicalTrials.gov Identifier: NCT03820128 |
Recruitment Status :
Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Pancreatitis | Other: Early diet intervention | Not Applicable |
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 |

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. |
- Length of hospitalization [ Time Frame: through study completion, an average of 2 years ]Number days of hospitalization
- 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
- 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
- Average calories intake [ Time Frame: through study completion, an average of 2 years ]Average calories intake (kcal)
- Levels of proinflammatory cytokine levels. [ Time Frame: through study completion, an average of 2 years ]Proinflammatory cytokine levels (ng/ml) using ELISA tests
- Zonulin level [ Time Frame: through study completion, an average of 2 years ]Zonulin level (ng/ml) using ELISA test

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Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820128
Contact: Aleksandra Banaszkiewicz, Ass. Prof. | 48 22 317 9451 | abanaszkiewicz@wum.edu.pl |
Poland | |
Departement of Paediatric Gastroenterology and Nutrition. | |
Warsaw, Poland, 02-091 |
Responsible Party: | Medical University of Warsaw |
ClinicalTrials.gov Identifier: | NCT03820128 |
Other Study ID Numbers: |
OZT |
First Posted: | January 29, 2019 Key Record Dates |
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 |
Pancreatitis Pancreatic Diseases Digestive System Diseases |