Spina BifidaANOSPINNCT02440984
Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function (ANOSPIN)
A study testing Colonic biopsies during endoscopy in people with Spina Bifida, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to assess and explain (at least apart) anorectal disorders of patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system and epithelial barrier dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Colonic biopsies during endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2015to 22 May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged between 18 and 65 years old
- patient who consulted to the national Spina Bifida Center for multidisciplinary assessment or for a proctology/urologic clinic
- need of colonic biopsies during endoscopy
- free, written and informed consent
Who cannot join
- pregnancy or breastfeeding
- protected adults (judicial protection, guardianship and truesteeship) and persons deprived of liberty
- patient unable to giving their consent
- anticoagulants therapy or coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function
The purpose of this study is to assess and explain (at least apart) anorectal disorders of patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier dysfunctions which explain anorectal disorders of these patients. Thexpect to show a decreased of 5% of enteric neurons per ganglia.
Read the detailed description
Spina Bifida is rare disease related to a failure of the closure of neural tube during the embryonic period. This malformation results in a variety of clinical disorders (neurologic, urologic, orthopedic, anorectal), depending on the level of the spinal cord lesion. Anorectal functional disorders remain underestimated and unknown from a pathophysiological point of view with subsequent uncodified therapeutic strategy.
Patients with Spina Bifida always present autonomic neuropathy that contributes partially to the anorectal disorders. These disorders may be related to a closed relationship between autonomic and enteric nervous system. Both nervous systems play a key role in anorectal disorders during others neurological disaeses have a common and simultaneous development from neural crest and induce colonic epithelial changes related to the closed connection between epithelial barrier and enteric nervous system. All of this remains hypothetic because no data regarding the impairment of enteric nervous system and epithelial barrier are available and no study are ongoing on this topic.
- Conditions
- Spina Bifida
- Being tested
- Colonic biopsies during endoscopy
- Keywords
- enteric nervous system, anorectal disorder, barostat anorectal, physiology, spina bifida
- Medical subject headings
- Spinal Dysraphism, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic biopsies during endoscopyProcedure or surgery
eligible patients will have physical examination, colonic biopsies during endoscopy and anal manometry with barostat. these investigations are part of the usual healthcare. Colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system.
| Study group | Role | What they receive |
|---|---|---|
| Enteric nervous system dysfunction | Other | colonic biopsies and usual care Receives: Procedure: Colonic biopsies during endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of enteric neurons per ganglia
all data will be collected in the Spina Bifida database for further analyses. 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)
anorectal symptoms
Measured: data collected at the day of endoscopy
Rectal compliance
Rectal compliance 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
Likert scale
Sensation intensity will be measured at each pressure step, by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)
Measured: data collected at the day of endoscopy
macroscopic and microscopic colonic inflammation
Measured: data collected at the day of endoscopy
intestinal permeability marker
Intestinal permeability will be measured using Ussing chamber.
Measured: data collected at the day of endoscopy
number of glia cells per ganglia
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 posted12 May 2015 (estimated)
- Study start15 Jun 2015
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies 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
- Enrolment
- 36 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
- NCT02440984
- Sponsor's protocol ID
- 2015-A00082-47
- Other IDs
- 35RC15_8926
- Acronym
- ANOSPIN
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2015
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Brochard 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 Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function
- ClinicalTrials.gov ID
- NCT02440984
- Acronym / sponsor ID
- ANOSPIN / 2015-A00082-47
- Conditions
- Spina Bifida
- Keywords
- enteric nervous system, anorectal disorder, barostat anorectal, physiology, spina bifida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
The purpose of this study is to assess and explain (at least apart) anorectal disorders of patients with Spina Bifida by an automatic neuropathy responsive of enteric nervous system and epithelial barrier dysfunctions. The investigators' aim hypothetics is that autonomic neuropathy of patients with Spina Bifida induce enteric nervous sytem and epithelial barrier dysfunctions which explain anorectal disorders of these patients. Thexpect to show a decreased of 5% of enteric neurons per ganglia.
Detailed description
Spina Bifida is rare disease related to a failure of the closure of neural tube during the embryonic period. This malformation results in a variety of clinical disorders (neurologic, urologic, orthopedic, anorectal), depending on the level of the spinal cord lesion. Anorectal functional disorders remain underestimated and unknown from a pathophysiological point of view with subsequent uncodified therapeutic strategy.
Patients with Spina Bifida always present autonomic neuropathy that contributes partially to the anorectal disorders. These disorders may be related to a closed relationship between autonomic and enteric nervous system. Both nervous systems play a key role in anorectal disorders during others neurological disaeses have a common and simultaneous development from neural crest and induce colonic epithelial changes related to the closed connection between epithelial barrier and enteric nervous system. All of this remains hypothetic because no data regarding the impairment of enteric nervous system and epithelial barrier are available and no study are ongoing on this topic.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteric nervous system dysfunction | Other | Procedure: Colonic biopsies during endoscopycolonic biopsies and usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient aged between 18 and 65 years old
- patient who consulted to the national Spina Bifida Center for multidisciplinary assessment or for a proctology/urologic clinic
- need of colonic biopsies during endoscopy
- free, written and informed consent
Key exclusion criteria (4 listed)
- pregnancy or breastfeeding
- protected adults (judicial protection, guardianship and truesteeship) and persons deprived of liberty
- patient unable to giving their consent
- anticoagulants therapy or coagulation disorders
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 |
|---|---|---|
| Colonic biopsies during endoscopyeligible patients will have physical examination, colonic biopsies during endoscopy and anal manometry with barostat. these investigations are part of the usual healthcare. Colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system. | Procedure or surgery | Enteric nervous system dysfunction |
Primary outcome
number of enteric neurons per ganglia
Time frame: data collected at the day of endoscopy
all data will be collected in the Spina Bifida database for further analyses. Colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system
6 secondary outcomes
anorectal symptoms
Time frame: data collected at the day of endoscopy
Rectal compliance
Time frame: data collected at the day of endoscopy
Likert scale
Time frame: data collected at the day of endoscopy
macroscopic and microscopic colonic inflammation
Time frame: data collected at the day of endoscopy
intestinal permeability marker
Time frame: data collected at the day of endoscopy
number of glia cells per ganglia
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 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 Colonic biopsies during endoscopy in people with Spina Bifida, 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 4 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 ganglia (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 NCT02440984, which also lists 1 linked publication.
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.