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Completed

NCT Number: NCT02440984

Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function (ANOSPIN)

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.

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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Rectal Diseases Spinal Dysraphism

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes University Hospital

Rennes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Colonic biopsies during endoscopy

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. anorectal symptoms

    Time frame: data collected at the day of endoscopy

  2. Rectal compliance

    Time frame: data collected at the day of endoscopy

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

  3. Likert scale

    Time frame: data collected at the day of endoscopy

    Sensation intensity will be measured at each pressure step, by using 6-point Likert scale ranging from 0 (no sensation) to 6 (intolerable pain)

  4. macroscopic and microscopic colonic inflammation

    Time frame: data collected at the day of endoscopy

  5. intestinal permeability marker

    Time frame: data collected at the day of endoscopy

    Intestinal permeability will be measured using Ussing chamber.

  6. number of glia cells per ganglia

    Time frame: data collected at the day of endoscopy

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function

Acronym: ANOSPIN

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 12, 2015
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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