Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects (ANOSAIN)
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|ClinicalTrials.gov Identifier: NCT03054415|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : December 23, 2019
This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in healthy subjects.
The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells. There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut functions. The characteristics and the phenotype of the ENS also change according to age and environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to assess abnormality of these items in patients with neurological disease including Spina Bifida.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Procedure: endoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects|
|Actual Study Start Date :||May 5, 2017|
|Actual Primary Completion Date :||September 14, 2017|
|Estimated Study Completion Date :||February 5, 2020|
colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip
- Number of enteric neurons per ganglion [ Time Frame: data collected at the day of endoscopy ]colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
- density and activity of the enteric glial cells [ Time Frame: data collected at the day of endoscopy ]colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
- rectal adaptation [ Time Frame: data collected at the day of endoscopy ]rectal adaptation is defined by a volume variation during ascending pressure (phasic distension). It will be performed with a bag connected to electronic barostat
- rectal perception [ Time Frame: data collected at the day of endoscopy ]It will performed by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)
- anal distensiblity [ Time Frame: data collected at the day of endoscopy ]It will be performed by using ENDOFLIP
- intestinal permeability [ Time Frame: data collected at the day of endoscopy ]Biopsy samples collected at the time of colonoscopy will be use within a Ussing Chamber able to assess intestinal permeability. The Ussing chamber is used to measure the short-circuit current as an indicator of net ion transport taking place across an epithelium, such as gut mucosa. The measure will be performed on 2 biopsies from each patient.
- macroscopic and microscopic colonic inflammation [ Time Frame: data collected at the day of endoscopy ]Colonic inflammation will be assessed during the scope procedure. The physician will assess the normality of the mucosa or not in case of mucosal erythema, ulceration or a decrease of the vascular pattern. Microscopic inflammation will be assessed by the pathologist according to neutrophils infiltration in the gut, crypt abscess, crypt distortion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054415
|Rennes University Hospital|
|Rennes, France, 35033|
|Principal Investigator:||Charlène BROCHARD, Md||Rennes University Hospital|