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

N/ACompletedNCT01990716

University Hospital, Toulouse124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

124

Conditions

Inflammatory Bowel Diseases Colitis, Ulcerative Crohn Disease

Interventions

Colonic BiopsyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Toulouse

Toulouse, France

Outcomes

Primary Outcomes

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

Time frame: 5 minutes

Secondary Outcomes

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).

Time frame: 5 minutes

Data from ClinicalTrials.gov

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