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

Not Applicable

Completed

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Other: Colonic Biopsy

• Registration Number: NCT01990716
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Colonic Biopsy	individuals undergoing screening colonic biopsy for colon cancer or polyp detection, who have not been diagnosed with any intestinal pathology.
IBD patients	Colonic Biopsy	Patients (diagnosed with IBD) having a screening colonic biopsy

Primary Outcome Measures

Name	Time	Method
Measure of 5,6-EET quantity in a colonic biopsy	5 minutes	Mass spectrography analysis of the biopsies will be performed each time at least 10 samples are available

Secondary Outcome Measures

Name	Time	Method
Nature and quantity of Lipid metabolites as a function of the patient clinical profile (mapping)	5 minutes	This measure will be performed at the same time than the first outcome measure (each time at least 10 samples are available).

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France