Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome (IBS)
Recruitment status was Active, not recruiting
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| First Received Date ICMJE | December 8, 2009 | ||||||||||||||||||||||||
| Last Updated Date | February 10, 2011 | ||||||||||||||||||||||||
| Start Date ICMJE | January 2006 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01028898 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome | ||||||||||||||||||||||||
| Official Title ICMJE | Screening and Identification of Abnormal Expression Proteins and miRNA From Colonic Mucosa of Patients With Irritable Bowel Syndrome. | ||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: 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. |
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| Sampling Method | Probability Sample | ||||||||||||||||||||||||
| Study Population | IBS patients (IBS-D and IBS-C)and healthy control |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 180 | ||||||||||||||||||||||||
| Estimated Completion Date | December 2012 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years to 60 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT01028898 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | IBS and metabolism | ||||||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||
| Responsible Party | YANG Yun-sheng, ChinaPLAGH | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Chinese PLA General Hospital | ||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Chinese PLA General Hospital | ||||||||||||||||||||||||
| Verification Date | December 2006 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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