Spinal Cord InjuriesTENS-SCINCT05954845
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
A study testing biopsies in people with Spinal Cord Injuries, run by Nantes University Hospital at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jul 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
CHU de Nantes service de gastroentérologie
Nantes, 44000
Guillaume VELUT, Dr, guillaume.velut@chu-nantes.fr
Guillaume VELUT, Dr
- Recruiting
CHU de Nantes service MPR
Nantes, 44000
Chloé LEFEVRE, Dr, chloe.lefevre@chu-nantes.fr
Chloé LEFEVRE, Dr
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- biopsies
- Keywords
- Spinal cord injury, Neurogastroenterology, Pathophysiology, Enteric nervous system, Intestinal epithelial barrier
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsiesOther
Biopsies will be obtained from the right and left colon (5 biopsies per colic region)
| Study group | Role | What they receive |
|---|---|---|
| patients with spinal cord injury | Experimental | Not described Receives: Other: biopsies |
| Control | Other | Patients with no spinal cord injury Receives: Other: biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of sulfonic acid and HRP flux in biopsies placed in Ussing chamber
Measured: 1 month
Quantifying the expression of junction molecules of the ZO-1 type
Measured: 1 month
Number of serotonin-producing cells labelled with anti-5-HT antibody
Measured: 1 month
The degree of expression of TPH1 and SERT in RT-qPCR
Measured: 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
Measured: 1 month
VIP, ACh and 5-HT concentration in the colonic mucosa
Measured: 1 month
Expression levels of key inflammation cytokines (TNFα, IL 1β, IFNɣ...)
Measured: 1 month
Secondary outcomes (2)
Correlation between intestinal permeability and type of neurological damage
Measured: 1 month
Correlation between intestinal permeability and degree of digestive function impairment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start24 Jul 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- participants will have colonic biopsies taken following a colonoscopy/rectosigmoidoscopy previously indicated. Biopsies will be obtained from the right and left colon.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954845
- Sponsor's protocol ID
- RC23_0075
- Acronym
- TENS-SCI
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05954845
- Acronym / sponsor ID
- TENS-SCI / RC23_0075
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, Neurogastroenterology, Pathophysiology, Enteric nervous system, Intestinal epithelial barrier
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants will have colonic biopsies taken following a colonoscopy/rectosigmoidoscopy previously indicated. Biopsies will be obtained from the right and left colon.
| Arm | Type | Receives |
|---|---|---|
| patients with spinal cord injury | Experimental | Other: biopsies |
| Control | Other | Other: biopsiesPatients with no spinal cord injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsiesBiopsies will be obtained from the right and left colon (5 biopsies per colic region) | Other | Control, patients with spinal cord injury |
Primary outcome
Measurement of sulfonic acid and HRP flux in biopsies placed in Ussing chamber
Time frame: 1 month
Quantifying the expression of junction molecules of the ZO-1 type
Time frame: 1 month
Number of serotonin-producing cells labelled with anti-5-HT antibody
Time frame: 1 month
The degree of expression of TPH1 and SERT in RT-qPCR
Time frame: 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
Time frame: 1 month
VIP, ACh and 5-HT concentration in the colonic mucosa
Time frame: 1 month
Expression levels of key inflammation cytokines (TNFα, IL 1β, IFNɣ...)
Time frame: 1 month
2 secondary outcomes
Correlation between intestinal permeability and type of neurological damage
Time frame: 1 month
Correlation between intestinal permeability and degree of digestive function impairment
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsies in people with Spinal Cord Injuries, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé LEFEVRE (02 40 84 60 66 ext. +33, chloe.lefevre@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of sulfonic acid and HRP flux in biopsies placed in Ussing chamber (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.