Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects (ANOSAIN)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: endoscopy

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Subjects	Procedure: endoscopy; colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Charlène Brochard, Md, Rennes University Hospital

Publications and helpful links

General Publications

• Lefevre C, Le Roy C, Bessard A, Le Berre-Scoul C, Marchix J, Coron E, Le Rhun M, Brochard C, Perrouin-Verbe B, Neunlist M. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients. Sci Rep. 2023 Oct 6;13(1):16902. doi: 10.1038/s41598-023-44057-y.
• Brochard C, Bouguen G, Olivier R, Durand T, Henno S, Peyronnet B, Pagenault M, Lefevre C, Boudry G, Croyal M, Fautrel A, Esvan M, Ropert A, Dariel A, Siproudhis L, Neunlist M. Altered epithelial barrier functions in the colon of patients with spina bifida. Sci Rep. 2022 May 3;12(1):7196. doi: 10.1038/s41598-022-11289-3.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): September 28, 2017
• Study Completion (Actual): September 28, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: neuronal-glial-epithelial unit, anorectal function
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy
• Other Study ID Numbers: 2016-A01541-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No