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Completed

NCT Number: NCT01990716

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonic Biopsy

Other

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.

Primary outcomes

  1. Measure of 5,6-EET quantity in a colonic biopsy

    Time frame: 5 minutes

    Mass spectrography analysis of the biopsies will be performed each time at least 10 samples are available

Secondary outcomes

  1. Nature and quantity of Lipid metabolites as a function of the patient clinical profile (mapping)

    Time frame: 5 minutes

    This measure will be performed at the same time than the first outcome measure (each time at least 10 samples are available).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: MICILIP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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