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NCT Number: 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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes service MPR, Nantes, France

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About this study

Injury to the spinal cord, whether traumatic or not, leads to numerous organ deficiencies, particularly vegetative deficiencies. Digestive and anorectal dysfunctions are among these, and are the main deficiencies that spinal cord injury patients would like to see disappear, even before motor recovery or walking, for example. However, the treatments available are essentially empirical (dietary hygiene rules, use of laxatives, digital exoneration maneuvers) and only partially effective.

Pathophysiological knowledge of digestive dysfunction in the medullo-injured is mainly focused on dysfunctions of extrinsic vegetative innervation. In contrast, there are few studies concerning the dysfunction of intrinsic digestive innervation in this pathology, i.e. the enteric nervous system (ENS), and the intestinal epithelial barrier (IEB), which are central players involved in the digestive disorders observed during the course of numerous digestive or extra-digestive pathologies, such as Parkinson's Disease (PD) in particular.

To date, the nature of ENS/EIB remodeling has not been correlated with clinical data, in order to potentially link it to a clinical phenotype of these patients, and to determine their capacity to become predictive biomarkers of disease progression, severity and/or response to treatment. By combining functional exploration of the intestinal barrier, protein and transcriptomic analysis of biopsies, the aim is to 1) characterize functional (permeability, serotonin production), proteomic and transcriptomic remodeling of the mucosa in SCI patients compared with control groups, 2) make the link with patients' clinical data, 3) identify markers of disease severity (lesion level, severity of intestinal dysfunction) and 4) identify therapeutic targets that could be tested in the animal model before being proposed in clinical trials.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for patient with spinal cord injury:

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

Inclusion criteria

for control group:

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.

Exclusion criteria

for patients with spinal cord injury:

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

Exclusion criteria

for control group:

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)

Treatment and study plan

biopsies

Other

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

Primary outcomes

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

    Time frame: 1 month

  2. Quantifying the expression of junction molecules of the ZO-1 type

    Time frame: 1 month

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

    Time frame: 1 month

  4. The degree of expression of TPH1 and SERT in RT-qPCR

    Time frame: 1 month

  5. 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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 1 month

Secondary outcomes

  1. Correlation between intestinal permeability and type of neurological damage

    Time frame: 1 month

  2. Correlation between intestinal permeability and degree of digestive function impairment

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Chloé LEFEVRE

CONTACT

[email protected]

02 40 84 60 66 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

The Enteric Nervous System in Spinal Cord Injury : étude du système Nerveux entérique et de la barrière épithéliale Intestinale Via la réalisation de Biopsies Coliques Chez Les Patients Porteurs de lésion médullaire

Acronym: TENS-SCI

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2023
Registry last updated
Apr 17, 2026

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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