NCT07313085

Brief Summary

In order to clarify the mechanism of fecal incontinence in in Wolfram syndrome and to characterize its risk factors, the examiner will reviewed the files of patients followed in a Reference Center for Rare Diseases in Ophthalmology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 15, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

12 days

First QC Date

November 15, 2025

Last Update Submit

December 22, 2025

Conditions

Wolfram SyndromeFecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary disorders

    number of patients with urinary disorder in each group according to the group

    The date at the baseline

Secondary Outcomes (4)

  • sleep apnea

    The date the data will be analyzed at the baseline

  • frequence of swallowing disroder

    The data will be analyzed at baseline

  • frequence of diabetes insipidus

    The data will be analyzed at baseline

  • mutation type

    The data will be analyzed at baseline

Study Arms (2)

Wolfram syndrome patients with fecal incontience

wolfram syndrome patients without fecal incontinence

Other: Retrospective case-control analysis

Wolfram syndrome patients without fecal incontience

Other: Retrospective case-control analysis

Interventions

Retrospective case-control analysisOTHER

retrospective analysis of data

Wolfram syndrome patients with fecal incontienceWolfram syndrome patients without fecal incontience

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospectif cohort of the rare disease center

You may qualify if:

  • Wolfram syndrome

You may not qualify if:

  • no information concerning fecal incontinence in data records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HEGP

Paris, 75015, France

Location

MeSH Terms

Conditions

Wolfram SyndromeFecal Incontinence

Condition Hierarchy (Ancestors)

Deaf-Blind DisordersDeafnessHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesOptic Atrophies, HereditaryOptic AtrophyOptic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesSensation DisordersNeurologic ManifestationsBlindnessVision DisordersEye Diseases, HereditaryEye DiseasesDiabetes InsipidusKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornDiabetes Mellitus, Type 1Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPituitary DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

christophe Orssaud, MD

CONTACT

33 156093466christophe.orssaud@aphp.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

November 15, 2025

First Posted

December 31, 2025

Study Start

December 20, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

FR(1)