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

NCT03054415 | Completed

• 1 other identifier: 2016-A01541-50
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

neuronal-glial-epithelial unit, anorectal function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• density and activity of the enteric glial cells

  data collected at the day of endoscopy

• rectal adaptation

  data collected at the day of endoscopy

• rectal perception

  data collected at the day of endoscopy

• anal distensiblity

  data collected at the day of endoscopy

• intestinal permeability

  data collected at the day of endoscopy

Study Arms (1)

Healthy Subjects

OTHER

Procedure: endoscopy

Interventions

endoscopy PROCEDURE

colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip

Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under guardianship or unable to give their consent;

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

Related Publications (2)

• 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.

  PMID: 37803037 DERIVED

• 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.

  PMID: 35505001 DERIVED

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Charlène BROCHARD, Md

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: May 5, 2017
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)