Comprehensive DNA Methylation Profiling in Crohn's Disease

August 31, 2017 updated by: Jianan Ren, Jinling Hospital, China

Comprehensive DNA Methylation Profiling of Inflammatory and Non-Inflammatory Mucosa in Crohn's Disease

Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was determined using the Illumina HumanMethylation 850k BeadChip.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with active Crohn's disease who underwent colonoscopy at Jinling Hospital

Description

Inclusion Criteria:

  • Active Crohn's disease(CDAI score≥ 150)

Exclusion Criteria:

  • No ileal lesions
  • Under treatment of immunomodulators, biologic agents or steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inflamed CD group
Inflamed ileal mucosa was obtained from inflammed lesions of active CD patients
Genetic: Genome-wide DNA methylation
Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.
Non-inflamed CD group
Non-inflamed ileal mucosa was obtained from normal sites of active CD patients
Genetic: Genome-wide DNA methylation
Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.
Control group
Control ileal mucosa was obtained from healthy patients
Genetic: Genome-wide DNA methylation
Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal inflammation under colonoscopy
Time Frame: Jan 2017 to Sep 2017
Intestinal ulcer or enteritisis observed under colonoscopy
Jan 2017 to Sep 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDAI
Time Frame: Jan 2017 to Sep 2017
Crohns Disease Activity Index is measured.
Jan 2017 to Sep 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 30, 2017

Study Completion (Anticipated)

September 30, 2017

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease

Clinical Trials on Genome-wide DNA methylation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe