Cerebral Resonance Magnetic Imaging During Rectal Distention | NCT00213330

Studies
Cerebral Resonance Magnetic Imaging During Rectal Distention

NCT00213330

Sponsor

University Hospital, Rouen

Status

Withdrawn

Last Update Posted

Apr 23, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Ulcerative Colitis
Irritable Bowel Syndrome

Interventions

rectal distension

Countries

France

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

patients with inflammatory colitis not included

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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

Apr 20, 2012

Last Update Posted Date

Apr 23, 2012Estimated

Description Module

Brief Summary

Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.

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

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
rectal distension	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects irritable bowel syndrome (Rome II criteria) colitis ulcerative

Exclusion Criteria:

pregnant or breast feeding metallic material implanted good tolerance of rectal distension acute phase of ulcerative colitis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

healthy subjects and patients with irritable bowel syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Gérardin, MD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital of Rouen		Rouen		76031	France

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided