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

NCT05954845 | Recruiting

• 1 other identifier: RC23_0075
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Spinal Cord Injuries

Keywords

Spinal cord injury, Neurogastroenterology, Pathophysiology, Enteric nervous system, Intestinal epithelial barrier

Outcome Measures

Primary Outcomes (7)

• Measurement of sulfonic acid and HRP flux in biopsies placed in Ussing chamber

  1 month

• Quantifying the expression of junction molecules of the ZO-1 type

  1 month

• Number of serotonin-producing cells labelled with anti-5-HT antibody

  1 month

• The degree of expression of TPH1 and SERT in RT-qPCR

  1 month

• Calculation of the number of neurons and the proportion of different neurochemical phenotypes of neurons in relation to the total number of neurons in the submucosal plexus

  1 month

• VIP, ACh and 5-HT concentration in the colonic mucosa

  1 month

• Expression levels of key inflammation cytokines (TNFα, IL 1β, IFNɣ...)

  1 month

Secondary Outcomes (2)

• Correlation between intestinal permeability and type of neurological damage

  1 month

• Correlation between intestinal permeability and degree of digestive function impairment

  1 month

Study Arms (2)

patients with spinal cord injury

EXPERIMENTAL

Other: biopsies

Control

OTHER

Patients with no spinal cord injury

Other: biopsies

Interventions

biopsies OTHER

Biopsies will be obtained from the right and left colon (5 biopsies per colic region)

Control; patients with spinal cord injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with signed consent Patient over 18 and under 80 years of age Patient with acquired traumatic or non-traumatic spinal cord injury Patient with an indication for colonoscopy or rectosigmoidoscopy at the Nantes University Hospital Gastroenterology Department Eligible for French social security Patient enrolled in the COSCINUS cohort
• Subject with signed consent Subject over 18 and under 80 years of age Subject free of any neurological pathology, with an indication for screening or preventive colonoscopy in the context of a personal or family history of polyps, or familial colon cancer, in the gastroenterology department of the Nantes University Hospital.

You may not qualify if:

• Patients in emergency situations, deprived of liberty, or not covered by the social security system Patient under legal protection Patient suffering from an inflammatory digestive disease Patient on anticoagulant therapy with no possibility of discontinuation or relay Patient with contraindications to colonoscopy/rectosigmoidoscopy Pregnant or breast-feeding patient
• Treatment with anticoagulants Treatment with antiaggregants Subject with a coagulation disorder Subject having finally an abnormal colonoscopy (discovery of any pathology other than one or more benign polyps)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU de Nantes service de gastroentérologie

Nantes, 44000, France

NOT YET RECRUITING

CHU de Nantes service MPR

Nantes, 44000, France

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Chloé LEFEVRE

CONTACT

02 40 84 60 66; chloe.lefevre@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants will have colonic biopsies taken following a colonoscopy/rectosigmoidoscopy previously indicated. Biopsies will be obtained from the right and left colon.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 20, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

FR (2)