Enteral Nutrition Product in Mild Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249963
• Other study ID #: ATEM2010
• Secondary ID: Atémpero IDI-200
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2010
• Last updated: June 21, 2012
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2011
• Source: Vegenat, S.A.
• Contact: Cristina Velasco Gimeno, BA
• Phone: +34 91 586 71 64
• Email: cvelasco.hgugm[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Pancreatitis
• Enteral Nutrition
• Pancreatitis

Intervention

Dietary Supplement:
• T-Diet plus Atémpero
T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
• AlitraQ (Abbott)
AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.

Locations

Country	Name	City	State
Spain	Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance, Tolerance and Nutritional Status	To compare the acceptance and tolerance of both products.; To compare the nutritional status in both arms.	1 year	No
Secondary	Inflammatory parameters evolution and EN complications	To compare the inflammatory parameters evolution in both arms.; To evaluate the enteral nutrition complications.	1 year	No