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

NCT ID: NCT02440984

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-15
• Study Completion Date: 2019-12-15

Brief 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. 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.

Conditions

Spina Bifida

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Enteric nervous system dysfunction

colonic biopsies and usual care

Group Type: OTHER

Colonic biopsies during endoscopy

Intervention Type: 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.

Interventions

Colonic biopsies during endoscopy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charlène Brochard, Md

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Charlène Brochard, Md

Role: CONTACT

charlene.brochard@chu-rennes.fr

Facility Contacts

Charlene Brochard, Md

Role: primary

charlene.brochard@chu-rennes.fr

References

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.

Reference Type: DERIVED

PMID: 35505001 (View on PubMed)

Other Identifiers

35RC15_8926

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A00082-47

Identifier Type: -

Identifier Source: org_study_id