Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborators:
National Research Agency, France
Solvay Pharmaceuticals
Information provided by:
Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT01154608
First received: June 30, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. We aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.


Condition Intervention
Pancreatitis
Drug: Creon
Other: No enzyme therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:
  • transfer of dietary nitrogen to metabolic pools [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: April 2005
Arms Assigned Interventions
Experimental: pancreatic enzymes Drug: Creon
Placebo Comparator: control Other: No enzyme therapy
Current enzyme therapy of the patient is stopped during 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic pancreatitis
  • Pancreatic insufficiency
  • Enzyme therapy treatment

Exclusion Criteria:

  • Hepatic failure
  • Pregnancy
  • Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01154608

Locations
France
Centre de Recherche sur Volontaires
Bobigny, France, 93000
Sponsors and Collaborators
Institut National de la Recherche Agronomique
National Research Agency, France
Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Pr Benamouzig, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01154608     History of Changes
Other Study ID Numbers: PANCREATITE
Study First Received: June 30, 2010
Last Updated: June 30, 2010
Health Authority: France: Health Administration

Keywords provided by Institut National de la Recherche Agronomique:
Protein absorption in pancreatitis
Protein metabolism in pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014