Genetic Contribution of Pain and Inflammation in IBS | NCT01436760

Studies
Genetic Contribution of Pain and Inflammation in IBS

NCT01436760

Sponsor

University of Florida

Status

Completed

Last Update Posted

Mar 26, 2012Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Irritable Bowel Syndrome

Interventions

Not provided

Countries

United States

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

Mar 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

May 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Sep 16, 2011

First Submission Date that Met QC Criteria

Sep 16, 2011

First Posted Date

Sep 20, 2011Estimated

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

Mar 23, 2012

Last Update Posted Date

Mar 26, 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

The goal of the study is to identify possible polymorphisms on the loci of candidate genes that may be involved in modulation of pain and inflammation in irritable bowel syndrome.

Detailed Description

Stored and de-linked blood or DNA from subjects with IBS will be utilized for analysis for possible polymorphisms at predetermined genetic loci located in chosen genes.

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

72Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Polymorphisms	The goal of the study isd to identify possible polymorphisms on the loci of canidate genes that may be involved in modulation of pain and inflammation in irritable Bowel Syndrome.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with IBS and previously stored samples

Exclusion Criteria:

Subjects without IBS and no previously stored samples

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Generic laboratory blood bank

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baharak Moshiree, MD, MS	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32610	United States

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided