NCT02512146

Brief Summary

The study aims to determine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

July 19, 2015

Last Update Submit

July 27, 2015

Conditions

Keywords

IBSIonotropic glutamate receptors

Outcome Measures

Primary Outcomes (2)

  • the expression of the ionotropic glutamate receptors

    Participants will examine the expression level of ionotropic glutamate receptors using quantitative real-time RT-PCR and western blot ,examine the distribution using immunohistochemy.

    4 months

  • the relationship between the ionotropic glutamate receptors and IBS symptom

    Symptoms will be assessed though the severity of abdominal pain or discomfort and seizure frequency.Participants will evaluate the relationship between the expression level or the distribution of ionotropic glutamate receptors and IBS symptom. If there is a link between them, participants will study the underlying molecular mechanisms.

    6 months

Study Arms (2)

Irritable bowel syndrome

Patients meeting Rome III criteria of irritable bowel syndrome. Intervention: colonoscopy.

Procedure: colonoscopy

Normal controls

Asymptomatic individuals for health surveillance or patients for follow up after polypectomy. Intervention: colonoscopy.

Procedure: colonoscopy

Interventions

colonoscopyPROCEDURE

Patients will undergo colonoscopy and participants will get biopsies from the colon.

Irritable bowel syndromeNormal controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent colonoscopy in Qilu Hospital outpatient and inpatient department.

You may qualify if:

  • Patients meeting IBS Rome III criteria. Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.

You may not qualify if:

  • Patients with known cancers or abdominal surgery. Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass. Patients who are unwilling to sign or give the informed consent form. Patients with impaired cardiac, liver or renal function. Patients with coagulopathy. Patients with pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Taken biopsies during Colonoscopy

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • xiuli zuo, PHD

    Department of Gastroenterology, Qilu Hospital

    STUDY DIRECTOR

Central Study Contacts

xiuli zuo, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 30, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations