Exploring the Enteric Nervous System in Spinal Cord Injury Patients
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
This study is trying to understand how spinal cord injuries affect the gut's nervous system and its ability to function properly, in hopes of finding better treatments for digestive issues in these patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 2 sites (Nantes and 1 other locations) |
| Trial ID | NCT05954845 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the enteric nervous system (ENS) and the intestinal epithelial barrier (IEB) in patients with spinal cord injuries. It will involve colonic biopsies to assess various parameters such as intestinal permeability, serotonin production, and the remodeling of the colonic mucosa. The study seeks to correlate these findings with the severity of neurological impairment and identify potential therapeutic targets for future treatments. By understanding the ENS and IEB in this patient population, the research hopes to provide insights that could lead to improved management of digestive dysfunctions associated with spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with acquired spinal cord injuries who require a colonoscopy or rectosigmoidoscopy.
Not a fit: Patients with inflammatory digestive diseases or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better treatment options for digestive dysfunctions in spinal cord injury patients.
How similar studies have performed: While there is limited research specifically on the ENS in spinal cord injury, studies on similar gastrointestinal dysfunctions in other neurological conditions suggest potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Nantes and 1 other locations
- CHU de Nantes service de gastroentérologie — Nantes, France (Not_yet_recruiting)
- CHU de Nantes service MPR — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Chloé LEFEVRE
- Email: chloe.lefevre@chu-nantes.fr
- Phone: 02 40 84 60 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.