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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01990716
Acronym
MICILIP
Enrollment
124
Registered
2013-11-21
Start date
2013-02-28
Completion date
2015-05-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

Keywords

Adult, Colonoscopy

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.

Interventions

OTHERColonic 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.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of 5,6-EET quantity in a colonic biopsy5 minutesMass spectrography analysis of the biopsies will be performed each time at least 10 samples are available

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026