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Enteral Nutrition Product in Mild Acute Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Vegenat, S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01249963
First received: November 26, 2010
Last updated: June 21, 2012
Last verified: February 2011
History of Changes
  Purpose

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

Condition Intervention
Acute Pancreatitis
Enteral Nutrition
 Dietary Supplement: T-Diet plus Atémpero
Dietary Supplement: AlitraQ (Abbott)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by Vegenat, S.A.:

Primary Outcome Measures:
  • Acceptance, Tolerance and Nutritional Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • To compare the inflammatory parameters evolution in both arms.
    • To evaluate the enteral nutrition complications.
Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Group
Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.
 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.
Other Name: ATEMP
Active Comparator: Control Diet
Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.
 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.
Other Name: ALIT

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249963

Contacts
Contact: Cristina Velasco Gimeno, BA +34 91 586 71 64 cvelasco.hgugm@salud.madrid.org

Locations
Spain
Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Cristina Velasco Gimeno, BA    +34 91 586 71 64    cvelasco.hgugm@salud.madrid.org   
Sponsors and Collaborators
Vegenat, S.A.
Investigators
Principal Investigator: Pilar García-Peris, PhD Hospital Universitario Gregorio Marañón
  More Information

No publications provided

Responsible Party: Vegenat, S.A.
ClinicalTrials.gov Identifier: NCT01249963     History of Changes
Other Study ID Numbers: ATEM2010, Atémpero IDI-20080283
Study First Received: November 26, 2010
Last Updated: June 21, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Vegenat, S.A.:
acute pancreatitis
enteral nutrition
nutritional status
pancreas
T-Diet plus Atémpero

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on March 02, 2015