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

R

Rennes University Hospital

Status

Unknown

Conditions

Healthy

Treatments

Procedure: endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03054415
2016-A01541-50

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Healthy Subjects
Other group
Treatment:
Procedure: endoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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