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Completed

NCT Number: NCT03054415

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

endoscopy

Procedure

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

Primary outcomes

  1. 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

  1. density and activity of the enteric glial cells

    Time frame: data collected at the day of endoscopy

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

  2. rectal adaptation

    Time frame: data collected at the day of endoscopy

    rectal adaptation is defined by a volume variation during ascending pressure (phasic distension). It will be performed with a bag connected to electronic barostat

  3. rectal perception

    Time frame: data collected at the day of endoscopy

    It will performed by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)

  4. anal distensiblity

    Time frame: data collected at the day of endoscopy

    It will be performed by using ENDOFLIP

  5. intestinal permeability

    Time frame: data collected at the day of endoscopy

    Biopsy 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.

  6. macroscopic and microscopic colonic inflammation

    Time frame: data collected at the day of endoscopy

    Colonic 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ANOSAIN

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2017
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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