NCT01028898

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 11, 2011

Status Verified

December 1, 2006

Enrollment Period

5.6 years

First QC Date

December 8, 2009

Last Update Submit

February 10, 2011

Conditions

Keywords

IBSproteomicsfluorescent quantitation polymerase chain reactionWestern blotimmunohistochemistry staining (IHC)ATP contentmicRNA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

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.

MeSH Terms

Conditions

Irritable Bowel SyndromeDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesColonic DiseasesColonic Diseases, Functional

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

January 1, 2006

Primary Completion

August 1, 2011

Study Completion

December 1, 2012

Last Updated

February 11, 2011

Record last verified: 2006-12