Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

June 30, 2010 updated by: Institut National de la Recherche Agronomique
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • Centre de recherche sur volontaires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic pancreatitis
  • Pancreatic insufficiency
  • Enzyme therapy treatment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
transfer of dietary nitrogen to metabolic pools

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Recherche Agronomique

Collaborators

National Research Agency, France
Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

July 1, 2010

Last Update Submitted That Met QC Criteria

June 30, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANCREATITE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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