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Enteral Nutrition Product in Mild Acute Pancreatitis

Primary Purpose

Acute Pancreatitis, Enteral Nutrition

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
T-Diet plus Atémpero
AlitraQ (Abbott)
Sponsored by
Vegenat, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pancreatitis focused on measuring acute pancreatitis, enteral nutrition, nutritional status, pancreas, T-Diet plus Atémpero

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio MarañónRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Diet

Arm Description

Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.

Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.

Outcomes

Primary Outcome Measures

Acceptance, Tolerance and Nutritional Status
To compare the acceptance and tolerance of both products. To compare the nutritional status in both arms.

Secondary Outcome Measures

Inflammatory parameters evolution and EN complications
To compare the inflammatory parameters evolution in both arms. To evaluate the enteral nutrition complications.

Full Information

First Posted
November 26, 2010
Last Updated
June 21, 2012
Sponsor
Vegenat, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01249963
Brief Title
Enteral Nutrition Product in Mild Acute Pancreatitis
Official Title
Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vegenat, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Enteral Nutrition
Keywords
acute pancreatitis, enteral nutrition, nutritional status, pancreas, T-Diet plus Atémpero

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.
Arm Title
Control Diet
Arm Type
Active Comparator
Arm Description
Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
T-Diet plus Atémpero
Other Intervention Name(s)
ATEMP
Intervention Description
T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
Intervention Type
Dietary Supplement
Intervention Name(s)
AlitraQ (Abbott)
Other Intervention Name(s)
ALIT
Intervention Description
AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.
Primary Outcome Measure Information:
Title
Acceptance, Tolerance and Nutritional Status
Description
To compare the acceptance and tolerance of both products. To compare the nutritional status in both arms.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inflammatory parameters evolution and EN complications
Description
To compare the inflammatory parameters evolution in both arms. To evaluate the enteral nutrition complications.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Velasco Gimeno, BA
Phone
+34 91 586 71 64
Email
cvelasco.hgugm@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar García-Peris, PhD
Organizational Affiliation
Hospital Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Velasco Gimeno, BA
Phone
+34 91 586 71 64
Email
cvelasco.hgugm@salud.madrid.org

12. IPD Sharing Statement

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Enteral Nutrition Product in Mild Acute Pancreatitis

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