search
Back to results

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

Primary Purpose

Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colonic Biopsy
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases focused on measuring Adult, Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

IBD patients

Control Group

Arm Description

Patients (diagnosed with IBD) having a screening colonic biopsy

individuals undergoing screening colonic biopsy for colon cancer or polyp detection, who have not been diagnosed with any intestinal pathology.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
November 15, 2013
Last Updated
February 21, 2017
Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT01990716
Brief Title
Lipid Mediators in Colonic Biopsies as Biomarkers of Disease Activity of Inflammatory Bowel Diseases
Acronym
MICILIP
Official Title
Quantitative Analysis of Lipid Mediators in Colonic Biopsies From Patients With Inflammatory Bowel Diseases and From Control Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
Keywords
Adult, Colonoscopy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBD patients
Arm Type
Other
Arm Description
Patients (diagnosed with IBD) having a screening colonic biopsy
Arm Title
Control Group
Arm Type
Other
Arm Description
individuals undergoing screening colonic biopsy for colon cancer or polyp detection, who have not been diagnosed with any intestinal pathology.
Intervention Type
Other
Intervention Name(s)
Colonic Biopsy
Intervention Description
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 Outcome Measure Information:
Title
Measure of 5,6-EET quantity in a colonic biopsy
Description
Mass spectrography analysis of the biopsies will be performed each time at least 10 samples are available
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Nature and quantity of Lipid metabolites as a function of the patient clinical profile (mapping)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Alric, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32234475
Citation
Rahabi M, Jacquemin G, Prat M, Meunier E, AlaEddine M, Bertrand B, Lefevre L, Benmoussa K, Batigne P, Aubouy A, Auwerx J, Kirzin S, Bonnet D, Danjoux M, Pipy B, Alric L, Authier H, Coste A. Divergent Roles for Macrophage C-type Lectin Receptors, Dectin-1 and Mannose Receptors, in the Intestinal Inflammatory Response. Cell Rep. 2020 Mar 31;30(13):4386-4398.e5. doi: 10.1016/j.celrep.2020.03.018.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs