Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

Sponsor

Institut National de la Recherche Agronomique (Other)

Overall Status

Completed

CT.gov ID

NCT01154608

Collaborator

National Research Agency, France (Other), Solvay Pharmaceuticals (Industry)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis	Drug: Creon Other: No enzyme therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Primary Purpose:

Basic Science

Study Start Date :

Apr 1, 2005

Arms and Interventions

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

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

Primary Outcome Measures

transfer of dietary nitrogen to metabolic pools []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche sur Volontaires	Bobigny		France	93000

Sponsors and Collaborators

Institut National de la Recherche Agronomique
National Research Agency, France
Solvay Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01154608

Other Study ID Numbers:

PANCREATITE

First Posted:

Jul 1, 2010

Last Update Posted:

Jul 1, 2010

Last Verified:

May 1, 2010

Keywords provided by , ,

Protein absorption in pancreatitis

Protein metabolism in pancreatitis

Additional relevant MeSH terms:

Pancreatitis

Study Results

No Results Posted as of Jul 1, 2010