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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03054415
Acronym
ANOSAIN
Enrollment
16
Registered
2017-02-15
Start date
2017-05-05
Completion date
2017-09-28
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

neuronal-glial-epithelial unit, anorectal function

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.

Interventions

PROCEDUREendoscopy

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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Number of enteric neurons per gangliondata collected at the day of endoscopycolonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system

Secondary

MeasureTime frameDescription
density and activity of the enteric glial cellsdata collected at the day of endoscopycolonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
rectal adaptationdata collected at the day of endoscopyrectal adaptation is defined by a volume variation during ascending pressure (phasic distension). It will be performed with a bag connected to electronic barostat
rectal perceptiondata collected at the day of endoscopyIt will performed by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)
anal distensiblitydata collected at the day of endoscopyIt will be performed by using ENDOFLIP
intestinal permeabilitydata collected at the day of endoscopyBiopsy 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 inflammationdata collected at the day of endoscopyColonic 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCharlène BROCHARD, Md

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026