Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Procedure: endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject aged between 18 and 65 years old age and sex matched with the first sixteen patients included and evaluated in the ANOSPIN study subject who gave their written consent to participate to the present study subject not included in another study subject covered by social insurance system Exclusion Criteria: Pregnant or nursing women; Anticoagulants therapy or coagulation disorders; Past history of anal or rectal surgery Crohn disease or ulcerative colitis Irritable bowel syndrome according to the Rome III criteria; Past history of pelvic radiotherapy Pas history of rectal or anal cancer Anorectal symptoms : faecal incontinence, constipation, anorectal pain, rectal prolapse; CCIS >5 (faecal incontinence); Kess Score >9 (constipation); Colonic irrigation; Use of laxatives; Abnormal colonic mucosa Period of exclusion; Patient under guardianship or unable to give their consent;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Subjects<br> | Procedure: endoscopy<br>* colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of enteric neurons per ganglion | colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system | data collected at the day of endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| density and activity of the enteric glial cells | colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system | data collected at the day of endoscopy | 
| rectal adaptation | rectal adaptation is defined by a volume variation during ascending pressure (phasic distension). It will be performed with a bag connected to electronic barostat | data collected at the day of endoscopy | 
| rectal perception | It will performed by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain) | data collected at the day of endoscopy | 
| anal distensiblity | It will be performed by using ENDOFLIP | data collected at the day of endoscopy | 
| intestinal permeability | 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. | data collected at the day of endoscopy | 
| macroscopic and microscopic colonic inflammation | 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. | data collected at the day of endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuronal-glial-epithelial unit, anorectal function