Wolfram SyndromeNCT07313085
Mechanisms of Fecal Incontinence in Wolfram Syndrome
An observational study of Wolfram Syndrome and Fecal Incontinence, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wolfram Syndrome, Fecal Incontinence
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2025to Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: retrospectif cohort of the rare disease center
Who may be able to join
- Wolfram syndrome
Who cannot join
- no information concerning fecal incontinence in data records
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Wolfram Syndrome, Fecal Incontinence
- Being tested
- Retrospective case-control analysis
- Medical subject headings
- Wolfram Syndrome, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective case-control analysisOther
retrospective analysis of data
| Study group | Role | What they receive |
|---|---|---|
| Wolfram syndrome patients with fecal incontience | wolfram syndrome patients without fecal incontinence Receives: Other: Retrospective case-control analysis | |
| Wolfram syndrome patients without fecal incontience | Not described Receives: Other: Retrospective case-control analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary disorders
number of patients with urinary disorder in each group according to the group
Measured: The date at the baseline
Secondary outcomes (4)
sleep apnea
number of patients with sleep apnea in each group according to the group
Measured: The date the data will be analyzed at the baseline
frequence of swallowing disroder
number of patients with swallowing disorders in each group according to the group
Measured: The data will be analyzed at baseline
frequence of diabetes insipidus
number of patients with diabetes insipidus in each group according to the group
Measured: The data will be analyzed at baseline
mutation type
report of mutations of WFS1 in each group
Measured: The data will be analyzed at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wolfram SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Orssaud, UF Ophthalmology HEGP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313085
- Sponsor's protocol ID
- FECINCONTWS1125
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided