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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054415
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Healthy Procedure: endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : September 14, 2017
Estimated Study Completion Date : February 5, 2020

Arm Intervention/treatment
Healthy Subjects Procedure: endoscopy
colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054415


Locations
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France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Charlène BROCHARD, Md Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03054415    
Other Study ID Numbers: 2016-A01541-50
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
neuronal-glial-epithelial unit, anorectal function