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Clinical Trials/NCT03054415
NCT03054415
Unknown
Not Applicable

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

Rennes University Hospital1 site in 1 country16 target enrollmentMay 5, 2017
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Rennes University Hospital
Enrollment
16
Locations
1
Primary Endpoint
Number of enteric neurons per ganglion
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2017
End Date
February 5, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

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);

Outcomes

Primary Outcomes

Number of enteric neurons per ganglion

Time Frame: data collected at the day of endoscopy

colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system

Secondary Outcomes

  • 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)
  • macroscopic and microscopic colonic inflammation(data collected at the day of endoscopy)

Study Sites (1)

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