Irritable Bowel SyndromeIBSNCT01028898
Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome and Digestive System Diseases, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: IBS patients (IBS-D and IBS-C)and healthy control
Who may be able to join
- Patients with symptoms meeting Rome III criteria for diagnosis of IBS-C and IBS-D
Who cannot join
- 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
About this study
Official title: Screening and Identification of Abnormal Expression Proteins and miRNA From Colonic Mucosa of Patients With Irritable Bowel Syndrome.
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.
Read the 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
- 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
- Medical subject headings
- Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Colonic Diseases, Colonic Diseases, Functional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2006
- Primary completionAug 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- YANG Yun-sheng, MD, Study chair, Chinese PLA General HospitalZHANG Chun-yan, doctor, Principal investigator, Chinese PLA General HospitalWANG Weifeng, doctor, Principal investigator, Chinese PLA General HospitalYAO XIN, DOCTOR, Principal investigator, Chinese PLA General HospitalPENG LIHUA, DOCTOR, Principal investigator, Chinese PLA General HospitalYU YUANZI, DOCTOR, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028898
- Sponsor's protocol ID
- IBS and metabolism
- Acronym
- IBS
- Status last verified
- Dec 2006
- First submitted
- 8 Dec 2009
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23840124
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Identification of Abnormal Expression Proteins and miRNA From Colonic Mucosa of Patients With Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT01028898
- Acronym / sponsor ID
- IBS / IBS and metabolism
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- IBS patients (IBS-D and IBS-C)and healthy control
Key inclusion criteria (1 listed)
- Patients with symptoms meeting Rome III criteria for diagnosis of IBS-C and IBS-D
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Derived from this study: PubMed 23840124Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YANG Yun-sheng, MD study chair
Chinese PLA General Hospital
ZHANG Chun-yan, doctor principal investigator
Chinese PLA General Hospital
WANG Weifeng, doctor principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome and Digestive System Diseases, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.