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Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT01154608
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : July 1, 2010
Sponsor:
Collaborators:
National Research Agency, France
Solvay Pharmaceuticals
Information provided by:
Institut National de la Recherche Agronomique

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatitis Drug: Creon Other: No enzyme therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Basic Science
Study Start Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: pancreatic enzymes Drug: Creon
Placebo Comparator: control Other: No enzyme therapy
Current enzyme therapy of the patient is stopped during 7 days


Outcome Measures
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Primary Outcome Measures :
  1. transfer of dietary nitrogen to metabolic pools

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154608


Locations
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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
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Responsible Party: Pr Benamouzig, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01154608    
Other Study ID Numbers: PANCREATITE
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: May 2010
Keywords provided by Institut National de la Recherche Agronomique:
Protein absorption in pancreatitis
Protein metabolism in pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases