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Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

Primary Purpose

Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Creon
No enzyme therapy
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pancreatitis focused on measuring Protein absorption in pancreatitis, Protein metabolism in pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic pancreatitis
  • Pancreatic insufficiency
  • Enzyme therapy treatment

Exclusion Criteria:

  • Hepatic failure
  • Pregnancy
  • Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease

Sites / Locations

  • Centre de Recherche sur Volontaires

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pancreatic enzymes

control

Arm Description

Outcomes

Primary Outcome Measures

transfer of dietary nitrogen to metabolic pools

Secondary Outcome Measures

Full Information

First Posted
June 30, 2010
Last Updated
June 30, 2010
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
National Research Agency, France, Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01154608
Brief Title
Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
National Research Agency, France, Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Protein absorption in pancreatitis, Protein metabolism in pancreatitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pancreatic enzymes
Arm Type
Experimental
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Creon
Intervention Type
Other
Intervention Name(s)
No enzyme therapy
Intervention Description
Current enzyme therapy of the patient is stopped during 7 days
Primary Outcome Measure Information:
Title
transfer of dietary nitrogen to metabolic pools

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic pancreatitis Pancreatic insufficiency Enzyme therapy treatment Exclusion Criteria: Hepatic failure Pregnancy Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease
Facility Information:
Facility Name
Centre de Recherche sur Volontaires
City
Bobigny
ZIP/Postal Code
93000
Country
France

12. IPD Sharing Statement

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Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

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