Acute Pancreatitis | Enteral Nutrition Product in Mild Acute Pancreatitis
Acute Pancreatitis research study
What is the primary objective of this study?
The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product. The main objectives of this project are: - Comparing the tolerance of both preparations. - Comparing the evolution of nutritional status in both groups. - Comparing the evolution of inflammatory parameters in both groups
Who is eligible to participate?
Inclusion Criteria: - Patients over 18 with Mild Acute Pancreatitis. Exclusion Criteria: - Patients with Several Acute Pancreatitis - Patients with life expectancy less than 48 hours. - Renal (creatinin > 2,5 mg/dl) or kidney failure (GOT/GPT>2 from laboratory normal value) - Patients with diabetes mellitus prior to acute pancreatitis. - To take part in another study. - Pregnant patients - Informed consent absence.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:T-Diet plus AtémperoT-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
Dietary Supplement:AlitraQ (Abbott)AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Experimental GroupPatients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.
Control DietPatients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.
Start Date: February 2011
Completed Date: March 2013
Primary Outcome: Acceptance, Tolerance and Nutritional Status
Secondary Outcome: Inflammatory parameters evolution and EN complications
Study sponsors, principal investigator, and references
Principal Investigator: Pilar García-Peris, PhD
Lead Sponsor: Vegenat, S.A.