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

Healthy Clinical Trial

— ANOSAIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03054415
• Other study ID #: 2016-A01541-50
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: February 5, 2020

Study information

• Verified date: December 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: February 5, 2020
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• endoscopy
colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	anal distensiblity	It will be performed by using ENDOFLIP	data collected at the day of endoscopy
Secondary	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
Secondary	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