HealthyANOSAINNCT03054415
Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects
A study testing endoscopy in people with Healthy, run by Rennes University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- endoscopy
- Keywords
- neuronal-glial-epithelial unit, anorectal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Other | Not described Receives: Procedure: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enteric neurons per ganglion
colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
Measured: data collected at the day of endoscopy
Secondary outcomes (6)
density and activity of the enteric glial cells
colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
Measured: data collected at the day of endoscopy
rectal adaptation
rectal adaptation is defined by a volume variation during ascending pressure (phasic distension). It will be performed with a bag connected to electronic barostat
Measured: data collected at the day of endoscopy
rectal perception
It will performed by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)
Measured: data collected at the day of endoscopy
anal distensiblity
It will be performed by using ENDOFLIP
Measured: data collected at the day of endoscopy
intestinal permeability
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.
Measured: data collected at the day of endoscopy
macroscopic and microscopic colonic inflammation
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.
Measured: data collected at the day of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start5 May 2017
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlène BROCHARD, Md, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054415
- Sponsor's protocol ID
- 2016-A01541-50
- Acronym
- ANOSAIN
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2017
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lefevre C, Le Roy C, Bessard A, Le Berre-Scoul C, Marchix J, Coron E, Le Rhun M, Brochard C, Perrouin-Verbe B, Neunlist M. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients. Sci Rep. 2023 Oct 6;13(1):16902. doi: 10.1038/s41598-023-44057-y.
PubMed 37803037Brochard 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.
PubMed 35505001
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03054415
- Acronym / sponsor ID
- ANOSAIN / 2016-A01541-50
- Conditions
- Healthy
- Keywords
- neuronal-glial-epithelial unit, anorectal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Other | Procedure: endoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopycolonic biopsies during endoscopy and anal manometry with barostat and anal endoflip | Procedure or surgery | Healthy Subjects |
Primary outcome
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
6 secondary outcomes
density and activity of the enteric glial cells
Time frame: data collected at the day of endoscopy
rectal adaptation
Time frame: data collected at the day of endoscopy
rectal perception
Time frame: data collected at the day of endoscopy
anal distensiblity
Time frame: data collected at the day of endoscopy
intestinal permeability
Time frame: data collected at the day of endoscopy
macroscopic and microscopic colonic inflammation
Time frame: data collected at the day of endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 37803037Lefevre C, Le Roy C, Bessard A, Le Berre-Scoul C, Marchix J, Coron E, Le Rhun M, Brochard C, Perrouin-Verbe B, Neunlist M. Region-specific remodeling of the enteric nervous system and enteroendocrine cells in the colon of spinal cord injury patients. Sci Rep. 2023 Oct 6;13(1):16902. doi: 10.1038/s41598-023-44057-y.
- Derived from this study: PubMed 35505001Brochard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlène BROCHARD, Md principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy in people with Healthy, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of enteric neurons per ganglion (time frame: data collected at the day of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03054415, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.