Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome (IBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Chinese PLA General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01028898
First received: December 8, 2009
Last updated: February 10, 2011
Last verified: December 2006
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Screening and Identification of Abnormal Expression Proteins and miRNA From Colonic Mucosa of Patients With Irritable Bowel Syndrome.

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Biospecimen Retention:   Samples With DNA

The investigators enrolled IBS-D and IBS-C patients on the Rome III criteria and healthy volunteers as normal control group. Biopsies were taken from the cecum and sigmoid colon under direct vision. Five pieces were taken separately at each site. Four pieces were processed by cold saline water and frozen in liquid nitrogen immediately while the other one was fixed in formalin and then embedded in paraffin three days later.


Estimated Enrollment: 180
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028898

Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: YANG Yun-sheng, MD Chinese PLA General Hospital
Principal Investigator: 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
  More Information

No publications provided by Chinese PLA General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: YANG Yun-sheng, ChinaPLAGH
ClinicalTrials.gov Identifier: NCT01028898     History of Changes
Other Study ID Numbers: IBS and metabolism
Study First Received: December 8, 2009
Last Updated: February 10, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
IBS
proteomics
fluorescent quantitation polymerase chain reaction
Western blot
immunohistochemistry staining (IHC)
ATP content
micRNA

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Colonic Diseases, Functional
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014