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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

November 26, 2010
June 21, 2012
February 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01249963 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Enteral Nutrition Product in Mild Acute Pancreatitis
Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Acute Pancreatitis
  • Enteral Nutrition
  • 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
  • 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
  • Experimental: Experimental Group
    Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.
    Intervention: Dietary Supplement: T-Diet plus Atémpero
  • Active Comparator: Control Diet
    Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.
    Intervention: Dietary Supplement: AlitraQ (Abbott)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Cristina Velasco Gimeno, BA +34 91 586 71 64 cvelasco.hgugm@salud.madrid.org
Spain
 
NCT01249963
ATEM2010, Atémpero IDI-20080283
No
Vegenat, S.A.
Vegenat, S.A.
Not Provided
Principal Investigator: Pilar García-Peris, PhD Hospital Universitario Gregorio Marañón
Vegenat, S.A.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP