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 - Trial NCT05954845
Access comprehensive clinical trial information for NCT05954845 through Pure Global AI's free database. This phase not specified trial is sponsored by Nantes University Hospital and is currently Not yet recruiting. The study focuses on Spinal Cord Injuries. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
Nantes University Hospital
Timeline & Enrollment
N/A
Jul 01, 2023
Oct 01, 2025
Primary Outcome
Measurement of sulfonic acid and HRP flux in biopsies placed in Ussing chamber,Quantifying the expression of junction molecules of the ZO-1 type,Number of serotonin-producing cells labelled with anti-5-HT antibody,The degree of expression of TPH1 and SERT in RT-qPCR,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,VIP, ACh and 5-HT concentration in the colonic mucosa,Expression levels of key inflammation cytokines (TNFα, IL 1β, IFNɣ...)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05954845
Non-Device Trial