Effects of Prednisolone and Infliximab on the Regulation... | NCT00955123

Studies
Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease

NCT00955123

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 12, 2012Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Not provided

Completion Date

Dec 2011Actual

First Submitted Date

Aug 3, 2009

First Submission Date that Met QC Criteria

Aug 5, 2009

First Posted Date

Aug 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2012

Last Update Posted Date

Oct 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active inflammatory bowel disease		Patients with moderate to severe active inflammatory bowel disease (ulcerative colitis and Crohn's disease)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional Hepatic Nitrogen Clearance		Before and one week after treatment

Secondary Outcomes

Measure	Description	Time Frame
Clinical and biochemical measures of inflammation		Before and one week after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe active inflammatory bowel disease

Exclusion Criteria:

Viral or bacterial infections
Other chronical inflammatory diseases
Cancer
Other catabolic diseases
Treatment with prednisolone or infliximab within the last 8 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients with active inflammatory bowel disease seen in the out-patients' clinic or admitted to hospital for treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Louise Thomsen, MD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine V, Aarhus University Hospital		Aarhus		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31159802	Derived	Hjortebjerg R, Thomsen KL, Agnholt J, Frystyk J. The IGF system in patients with inflammatory bowel disease treated with prednisolone or infliximab: potential role of the stanniocalcin-2 / PAPP-A / IGFBP-4 axis. BMC Gastroenterol. 2019 Jun 3;19(1):83. doi: 10.1186/s12876-019-1000-6.

ID	Term
D015212	Inflammatory Bowel Diseases
D007249	Inflammation

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases