Brain-derived Neurotrophic Factor Participates in Viscera... | NCT00925223

Studies
Brain-derived Neurotrophic Factor Participates in Visceral Hyperalgesia in Irritable Bowel Syndrome (IBS) Patients

NCT00925223

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Oct 14, 2009Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Irritable Bowel Syndrome

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
NSFC30570831

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Aug 2009Estimated

Completion Date

Nov 2009Estimated

First Submitted Date

Jun 18, 2009

First Submission Date that Met QC Criteria

Jun 19, 2009

First Posted Date

Jun 22, 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 13, 2009

Last Update Posted Date

Oct 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth factor family, has aroused attention as a modulator in visceral hyperalgesia recently. Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS patients.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
irritable bowel syndrome		patients with diarrhea-predominant IBS will be enrolled in this group.
control group		patients with colon cancer or colon polyp will be enrolled as control group.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with irritable bowel syndrome.

Exclusion Criteria:

Patients have similar clinical symptoms as IBS, yet there is morphologic changes in the intestine.

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

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel habits in the absence of structural and biochemical abnormalities.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yanqing Li, PhD. MD.	Department of Gastroenterology, Qilu Hospital, Shandong University	Study Director

Locations

Not provided

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