Enteral Nutrition Product in Mild Acute Pancreatitis
Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
2 other identifiers
interventional
40
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 22, 2012
February 1, 2011
1.8 years
November 26, 2010
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptance, Tolerance and Nutritional Status
* To compare the acceptance and tolerance of both products. * To compare the nutritional status in both arms.
1 year
Secondary Outcomes (1)
Inflammatory parameters evolution and EN complications
1 year
Study Arms (2)
Experimental Group
EXPERIMENTALPatients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.
Control Diet
ACTIVE COMPARATORPatients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.
Interventions
T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.
Eligibility Criteria
You may qualify if:
- Patients over 18 with Mild Acute Pancreatitis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vegenat, S.A.lead
Study Sites (1)
Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pilar García-Peris, PhD
Hospital Universitario Gregorio Marañón
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2010
First Posted
November 30, 2010
Study Start
February 1, 2011
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
June 22, 2012
Record last verified: 2011-02