NCT01154608

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
Last Updated

October 6, 2025

Status Verified

May 1, 2010

First QC Date

June 30, 2010

Last Update Submit

October 1, 2025

Conditions

Pancreatitis

Keywords

Protein absorption in pancreatitisProtein metabolism in pancreatitis

Outcome Measures

Primary Outcomes (1)

  • transfer of dietary nitrogen to metabolic pools

Study Arms (2)

pancreatic enzymes

EXPERIMENTAL
Drug: Creon

control

PLACEBO COMPARATOR
Other: No enzyme therapy

Interventions

CreonDRUG
pancreatic enzymes
No enzyme therapyOTHER

Current enzyme therapy of the patient is stopped during 7 days

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pancreatitis
  • Pancreatic insufficiency
  • Enzyme therapy treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche sur Volontaires

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

April 1, 2005

Last Updated

October 6, 2025

Record last verified: 2010-05

Locations

FR(1)