NCT02440984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

April 28, 2015

Last Update Submit

March 27, 2026

Conditions

Spina Bifida

Keywords

enteric nervous systemanorectal disorderbarostat anorectalphysiologyspina bifida

Outcome Measures

Primary Outcomes (1)

  • 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

    data collected at the day of endoscopy

Secondary Outcomes (6)

  • anorectal symptoms

    data collected at the day of endoscopy

  • Rectal compliance

    data collected at the day of endoscopy

  • Likert scale

    data collected at the day of endoscopy

  • macroscopic and microscopic colonic inflammation

    data collected at the day of endoscopy

  • intestinal permeability marker

    data collected at the day of endoscopy

  • +1 more secondary outcomes

Study Arms (1)

Enteric nervous system dysfunction

OTHER

colonic biopsies and usual care

Procedure: Colonic biopsies during endoscopy

Interventions

Colonic biopsies during endoscopyPROCEDURE

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.

Enteric nervous system dysfunction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, France

Location

Related Publications (1)

  • 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.

    PMID: 35505001DERIVED

MeSH Terms

Conditions

Spinal DysraphismRectal Diseases

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Charlène Brochard, Md

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 12, 2015

Study Start

June 15, 2015

Primary Completion

May 22, 2017

Study Completion

May 22, 2017

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

FR(1)