Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT05954845

The Enteric Nervous System in Spinal Cord Injury: Study of the Enteric Nervous System and the Intestinal Epithelial Barrier Via Colonic Biopsies in Spinal Cord Injury Patients

Led by Nantes University Hospital · Updated on 2026-04-17

40

Participants Needed

2

Research Sites

218 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn more about the enteric nervous system (ENS) and the intestinal epithelial barrier (IEB) in patients with spinal cord injury (SCI). The main questions it aims to answer are : * to characterize the functional (permeability, serotonin production, enteric neuronal phenotype, etc.), proteomic (junction molecules) and transcriptomic (inflammation genes, neuromediator expression, etc.) remodeling of the colonic mucosa and ENS in SCI patients, in comparison with control data. * to correlate intestinal permeability (and all remodeling parameters) with the type of neurological impairment i.e. the neurological level of the lesion, quantification of neurological impairment (motor and sensory scores) and the completeness and incompleteness of a lesion. * to identify a link with disease severity markers * to identify therapeutic targets that could subsequently be tested in the animal model before being proposed in clinical trials. Participants will have colonic biopsies taken following a colonoscopy/rectosigmoidoscopy previously indicated for spinal cord injured patients. Biopsies will be obtained from the right and left colon.

CONDITIONS

Official Title

The Enteric Nervous System in Spinal Cord Injury: Study of the Enteric Nervous System and the Intestinal Epithelial Barrier Via Colonic Biopsies in Spinal Cord Injury Patients

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed consent to participate
  • Aged between 18 and 80 years
  • Acquired traumatic or non-traumatic spinal cord injury (patients)
  • Indication for colonoscopy or rectosigmoidoscopy at Nantes University Hospital Gastroenterology Department (patients)
  • Eligible for French social security (patients)
  • Enrolled in the COSCINUS cohort (patients)
  • No neurological pathology and indication for screening or preventive colonoscopy due to personal or family history of polyps or familial colon cancer (controls)
  • Signed consent (controls)
  • Aged between 18 and 80 years (controls)
Not Eligible

You will not qualify if you...

  • Emergency situations or deprived of liberty
  • Not covered by social security
  • Under legal protection
  • Suffering from inflammatory digestive disease
  • On anticoagulant therapy without possibility of stopping or switching
  • Contraindications to colonoscopy or rectosigmoidoscopy
  • Pregnant or breastfeeding
  • Treatment with anticoagulants or antiaggregants (controls)
  • Coagulation disorder (controls)
  • Abnormal colonoscopy findings other than benign polyps (controls)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

CHU de Nantes service de gastroentérologie

Nantes, France, 44000

Not Yet Recruiting

2

CHU de Nantes service MPR

Nantes, France, 44000

Actively Recruiting

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Research Team

C

Chloé LEFEVRE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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