Chronic Intestinal Pathologies Analytical Cohort at TouLouse

Study Purpose

In the general population, the percentage of people with at least one digestive disease is 16.7%. Among these digestive diseases, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( FIT) in the stool will be studied. The aim of this project is to build a biological collection with associated clinical data for research projects.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient requiring endoscopic explorations for screening or follow-up in the context of a suspected IBS or IBD or colorectal cancer Or.
  • - Patient with IBD requiring surgical management.
  • - Patient over 18 years old.
  • - Patient able to read and understand the information leaflet.
  • - Patients who have given their consent to participate in the study.
  • - Patients affiliated to a social security system (including AME)

    Exclusion Criteria:

    - Patients who have received antibiotic treatments in the 10 days preceding endoscopic exploration.
  • - Pregnant or breastfeeding patients.
  • - Patients under 18 years old.
  • - Patients under guardianship or curatorship.
- Patients unable to sign a free and informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04896684
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Toulouse
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Diseases, Colon Cancer
Additional Details

In the general population, the percentage of people with at least one digestive disease is 16.7%. Among these digestive diseases, two of them namely inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) will be more particularly studied. This interest is based on the increasing frequency of these two pathologies, their chronicities but above all the limited physiopathological data available. In addition, it seems interesting to study a third population, namely patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( FIT) in the stool. The study of this population is part of an improvement in knowledge on the carcinogenesis of colorectal cancer. To study these populations, blood, serum, plasma and tissues from colonous biopsies or surgical samples will be collected. This cohort will make it possible to study, among other things, the pathophysiology of chronic diseases of the small intestine and the colon (IBD, IBS, screening) in order to improve their management through the development of new biomarkers and therapeutic targets.

Arms & Interventions

Arms

: Patient screened or followed-up for IBS or IBD or colorectal cancer

Blood and colon biopsy sampling

Interventions

Biological: - blood and intestinal biopsy sampling

24 mL of blood and 10 intestinal biopsies will be sampled

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rangueil University Hospital, Toulouse, France

Status

Recruiting

Address

Rangueil University Hospital

Toulouse, , 31059

Site Contact

Barbara Bournet, MD, PhD

bournet.b@chu-toulouse.fr

5 61 32 32 35 #0033