- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07313085
Mechanisms of Fecal Incontinence in Wolfram Syndrome
December 22, 2025 updated by: Christophe Orssaud, Hôpital Necker-Enfants Malades
Physiopathogenic Mechanisms of Fecal Incontinence in Wolfram Syndrome
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: christophe Orssaud, MD
- Phone Number: 33 156093466
- Email: christophe.orssaud@aphp.fr
Study Locations
-
-
-
Paris, France, 75015
- HEGP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
retrospectif cohort of the rare disease center
Description
Inclusion Criteria:
- Wolfram syndrome
Exclusion Criteria:
- no information concerning fecal incontinence in data records
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Wolfram syndrome patients with fecal incontience
wolfram syndrome patients without fecal incontinence
|
retrospective analysis of data
|
|
Wolfram syndrome patients without fecal incontience
|
retrospective analysis of data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary disorders
Time Frame: The date at the baseline
|
number of patients with urinary disorder in each group according to the group
|
The date at the baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep apnea
Time Frame: The date the data will be analyzed at the baseline
|
number of patients with sleep apnea in each group according to the group
|
The date the data will be analyzed at the baseline
|
|
frequence of swallowing disroder
Time Frame: The data will be analyzed at baseline
|
number of patients with swallowing disorders in each group according to the group
|
The data will be analyzed at baseline
|
|
frequence of diabetes insipidus
Time Frame: The data will be analyzed at baseline
|
number of patients with diabetes insipidus in each group according to the group
|
The data will be analyzed at baseline
|
|
mutation type
Time Frame: The data will be analyzed at baseline
|
report of mutations of WFS1 in each group
|
The data will be analyzed at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 20, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
November 15, 2025
First Submitted That Met QC Criteria
December 22, 2025
First Posted (Actual)
December 31, 2025
Study Record Updates
Last Update Posted (Actual)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Nervous System Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genetic Diseases, Inborn
- Metabolic Diseases
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Rectal Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Eye Diseases
- Neurodegenerative Diseases
- Eye Diseases, Hereditary
- Congenital Abnormalities
- Otorhinolaryngologic Diseases
- Vision Disorders
- Sensation Disorders
- Abnormalities, Multiple
- Heredodegenerative Disorders, Nervous System
- Ear Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Pituitary Diseases
- Deaf-Blind Disorders
- Deafness
- Hearing Loss
- Hearing Disorders
- Blindness
- Optic Atrophies, Hereditary
- Optic Atrophy
- Diabetes Insipidus
- Diabetes Mellitus, Type 1
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nutritional and Metabolic Diseases
- Wolfram Syndrome
- Fecal Incontinence
Other Study ID Numbers
- FECINCONTWS1125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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