Lipid Mediators in Colonic Biopsies as Biomarkers of Disease Activity of Inflammatory Bowel Diseases

Crohn Disease Clinical Trial

— MICILIP  

Official title:

Quantitative Analysis of Lipid Mediators in Colonic Biopsies From Patients With Inflammatory Bowel Diseases and From Control Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990716
• Other study ID #: 12 393 02
• Secondary ID: AOL 2012
• Status: Completed
• Phase: N/A
• First received: November 15, 2013
• Last updated: February 21, 2017
• Start date: February 2013
• Est. completion date: May 2015

Study information

• Verified date: February 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6- EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We will evaluate its possible use as a pathological activity biomarker and its potential as a therapeutic target.

We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities depending on the pathological state of the IBD patient.

Description:

The project is an exploratory physiopathological/translational pilot study, aiming at understanding the relative importance of the lipid compounds, especially 5,6-EET, in Inflammatory Bowel Diseases.

Using mass spectrometry, 5,6-EET and other 33 lipid metabolites will be quantified in situ in colonic biopsies from IBD patients and from control patients. We will compare quantities of 5,6-EET in inflammatory and non-inflammatory zones of biopsies from IBD patient to biopsies from control patient. We will establish a cluster of lipid compounds associated with pathological activity. We will determine the exposed profile of receptor lipid mediators expressing to the 5,6-EET lipid compound and one of its signalization.

All data will be submit to statistical analysis to confirm relevance.

We expect this pilot study to help us define 5,6-EET and other components of the same metabolic family as markers for IBD activity. It could point lipid mediators and their receptors as potential new therapeutic targets.

It will increase our knowledge on current treatment efficiency by evidencing lipid markers for the inflammatory condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

INCLUSION CRITERIA FOR IBD PATIENTS

• Major/18 years and older

• Covered by a health insurance plan

• Patient having a screening colonoscopy for/with a suspicion of IBD or, IBD Patient, either in acute phase or in remission, having a therapeutic colonoscopy as part of his/her regular follow- up/usual care

• Must be able to understand and voluntarily sign an informed consent prior to any study procedures

INCLUSION CRITERIA FOR IBD PATIENTS

• Major/18 years and older Covered by a health insurance plan

• Patients having a screening colonoscopy for polyp or cancer detection or patient undergoing a colic resection

• Must be able to understand and voluntarily sign an informed consent prior to any study procedures

Exclusion Criteria:

EXCLUSION CRITERIA FOR IBD PATIENTS

• Unable to comprehend the full nature and purpose of the study, and/or difficulty in communicating with the investigator

• Deprivation of liberty by administrative or legal decision

• Any other pathological or psychological condition considered by the investigator as interfering with the study (pregnancy, breastfeeding, cancer detection, AIDS, celiac disease)

• Participation in another biomedical research/clinical trial with experimental medication within the last 3 months prior to the selection visit or patients still within a biomedical research exclusion period

• Presence of cancerous lesions

• Anatomopathological results excluding the possibility of an IBD

• Contra-indications to carrying out a lower digestive endoscopy

EXCLUSION CRITERIA FOR CONTROL PATIENTS

• Unable to comprehend the full nature and purpose of the study,

• and/or difficulty in communicating with the investigator

• Deprivation of liberty by administrative or legal decision

• Participation in another biomedical research/clinical trial with experimental medication within the last 3 months prior to the selection visit or patients still within a biomedical research exclusion period

• Contra-indications to carrying out a lower digestive endoscopy

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Colonic Biopsy
Colonoscopy or coloscopy can provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected colorectal cancer lesions. The endoscope is then passed through the anus up the rectum, the colon, and ultimately the terminal ileum. The endoscope has a movable tip and multiple channels for instrumentation, air, suction and light. Biopsies are frequently taken for histology, needed for cancer or IBD diagnosis. Extra-biopsies for research purpose will only be performed if the clinician decides that they are necessary for the clinical diagnosis or for the disease follow-up. For this protocol, collecting these extra biopsies should last under 5 minutes and should not extend the procedure by more than this time.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of 5,6-EET quantity in a colonic biopsy	Mass spectrography analysis of the biopsies will be performed each time at least 10 samples are available	5 minutes
Secondary	Nature and quantity of Lipid metabolites as a function of the patient clinical profile (mapping)	This measure will be performed at the same time than the first outcome measure (each time at least 10 samples are available).	5 minutes