Clinical trial NCT03054415: Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects
Official title: Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: neuronal-glial-epithelial unit, anorectal function
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Number of enteric neurons per ganglion
timeFrame: data collected at the day of endoscopy
Secondary outcomes:
measure: density and activity of the enteric glial cells
timeFrame: data collected at the day of endoscopy
measure: rectal adaptation
timeFrame: data collected at the day of endoscopy
measure: rectal perception
timeFrame: data collected at the day of endoscopy
measure: anal distensiblity
timeFrame: data collected at the day of endoscopy
measure: intestinal permeability
timeFrame: data collected at the day of endoscopy
measure: macroscopic and microscopic colonic inflammation
timeFrame: data collected at the day of endoscopy
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Charlène BROCHARD, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.