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:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

Drug Information available for: Phentermine Phentermine hydrochloride

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 (Adult, Senior)
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


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 Pancreatic Diseases Digestive System Diseases Phentermine Central Nervous System Stimulants Physiological Effects of Drugs Appetite Depressants	Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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