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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathogenic Mechanisms of Fecal Incontinence in Wolfram Syndrome
- ClinicalTrials.gov ID
- NCT07313085
- Acronym / sponsor ID
- FECINCONTWS1125
- Conditions
- Wolfram Syndrome, Fecal Incontinence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wolfram syndrome patients with fecal incontience | – | Other: Retrospective case-control analysiswolfram syndrome patients without fecal incontinence |
| Wolfram syndrome patients without fecal incontience | – | Other: Retrospective case-control analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- retrospectif cohort of the rare disease center
Key inclusion criteria (1 listed)
- Wolfram syndrome
Key exclusion criteria (1 listed)
- no information concerning fecal incontinence in data records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective case-control analysisretrospective analysis of data | Other | Wolfram syndrome patients with fecal incontience, Wolfram syndrome patients without fecal incontience |
Primary outcome
Urinary disorders
Time frame: The date at the baseline
number of patients with urinary disorder in each group according to the group
4 secondary outcomes
sleep apnea
Time frame: The date the data will be analyzed at the baseline
frequence of swallowing disroder
Time frame: The data will be analyzed at baseline
frequence of diabetes insipidus
Time frame: The data will be analyzed at baseline
mutation type
Time frame: The data will be analyzed at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Wolfram Syndrome
Active, not recruitingPhase 2
AMX0035 in Adult Patients With Wolfram Syndrome
Wolfram Syndrome
Active, not recruitingObservational study
Looking for VUS to Confirm Dominant Wolfram-like Syndrome Instead of Recessive Wolfram Syndrome
Optical Coherence Tomography (OCT) of the Retina, Mutation
Not yet recruitingObservational study
Does Recessive Optic Atrophy Due to WFS1 Exist?
Wolfram Syndrome 1, Optic Atrophies, Hereditary
RecruitingObservational study
Wolfram Syndrome and WFS1-related Disorders International Registry and Clinical Study
Wolfram Syndrome, Diabetes Mellitus
RecruitingObservational study
Monogenic Diabetes Misdiagnosed as Type 1
Diabetes Mellitus, Type 1, Monogenic Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wolfram Syndrome and Fecal Incontinence, run by Hôpital Necker-Enfants Malades at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact christophe Orssaud, MD (33 156093466, christophe.orssaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary disorders (time frame: The date at the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.