Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05954845 |
| Other study ID # |
RC23_0075 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 24, 2023 |
| Est. completion date |
October 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Nantes University Hospital |
| Contact |
Chloé LEFEVRE |
| Phone |
02 40 84 60 66 |
| Email |
chloe.lefevre[@]chu-nantes.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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, 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.
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.
