Abnormal Expression Proteins, Mitochondrial DNA and miRNA... | NCT01028898

Studies
Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome

NCT01028898

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Feb 11, 2011Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Irritable Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Colonic Diseases
Colonic Diseases, Functional

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

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2011Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 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

Feb 10, 2011

Last Update Posted Date

Feb 11, 2011Estimated

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

In the investigators study, the investigators will focus on the screening of the related proteins and miRNA to IBS in order to reveal the possible clues or molecular mechanism for this disorder.

Detailed Description

For the proteomic procedures, Our study groups extracted proteins from the cecum and sigmoid colon samples and ran on the two-dimensional gel electrophoresis (2-DE). The proteins on 2-DE were visualized by the silver stain, and then gel maps were scanned and analyzed with the Image Master 2D Elite. The obvious abnormal protein spots were identified by the mass spectrometry. Western blot 、 immunohistochemistry 、 mRNA and miRNA were also performed for further verification of the proteins.

Conditions Module

Conditions

Irritable Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Colonic Diseases
Colonic Diseases, Functional

Keywords

IBS
proteomics
fluorescent quantitation polymerase chain reaction
Western blot
immunohistochemistry staining (IHC)
ATP content
micRNA

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

180Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with symptoms meeting Rome III criteria for diagnosis of IBS-C and IBS-D

Exclusion Criteria:

Patients with organic illnesses or a history of major abdominal surgery
Major psychotic episode, mental retardation or dementia
Pregnant women and lactational women
Postinfectious IBS, PI-IBS

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

IBS patients (IBS-D and IBS-C)and healthy control

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
YANG Yun-sheng, MD	Chinese PLA General Hospital	Study Chair
ZHANG Chun-yan, doctor	Chinese PLA General Hospital	Principal Investigator
WANG Weifeng, doctor	Chinese PLA General Hospital	Principal Investigator
YAO XIN, DOCTOR	Chinese PLA General Hospital	Principal Investigator
PENG LIHUA, DOCTOR	Chinese PLA General Hospital	Principal Investigator
YU YUANZI, DOCTOR	Chinese PLA General Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23840124	Derived	Wang WF, Li X, Guo MZ, Chen JD, Yang YS, Peng LH, Wang YH, Zhang CY, Li HH. Mitochondrial ATP 6 and 8 polymorphisms in irritable bowel syndrome with diarrhea. World J Gastroenterol. 2013 Jun 28;19(24):3847-53. doi: 10.3748/wjg.v19.i24.3847.

ID	Term
D043183	Irritable Bowel Syndrome
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D003108	Colonic Diseases
D003109	Colonic Diseases, Functional