Gut bacteria and bacterial translocation in people with type 1 narcolepsy versus controls
Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients
This study will test whether the gut microbiome and bacterial translocation differ in people with type 1 narcolepsy compared with people without hypersomnolence problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Nîmes, Gard and 1 other locations) |
| Trial ID | NCT06292598 on ClinicalTrials.gov |
What this trial studies
This observational case-control study will compare gut microbiota composition and evidence of bacterial translocation in people with type 1 narcolepsy and matched control subjects. Researchers will collect stool, blood, and cerebrospinal fluid samples and analyze bacterial community structure, biodiversity indices, and markers of systemic translocation and inflammation. Participants are required to be French-speaking, insured, and free of recent antibiotic use, immunomodulatory therapy, or known dysimmune disease, and some NT1 participants will be followed over time. Analyses will control for body mass index and will explore relationships with disease duration and CSF orexin levels to look for links between microbiota changes and orexin neuron loss.
Who should consider this trial
Good fit: Ideal candidates are French-speaking, insured individuals with confirmed type 1 narcolepsy who are untreated at initial evaluation (and matched control subjects without hypersomnolence), and who have not used antibiotics or received immunomodulatory or chemotherapy treatment in the recent months.
Not a fit: People who have used antibiotics in the past three months, have a dysimmune condition, have received immunomodulatory therapy or chemotherapy within 60 days, cannot undergo or refuse lumbar puncture, or do not speak French are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could identify microbial signatures or translocation-related markers that help explain disease mechanisms and point to new prevention or treatment strategies for type 1 narcolepsy.
How similar studies have performed: Previous small studies have reported differences in fecal microbiota beta diversity and links between biodiversity and disease duration in NT1, but findings are preliminary and clinical relevance remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient diagnosed with narcolepsy type 1 (NT1). * Patient not treated for narcolepsy during initial evaluation of NT1 patients. * Patient eligible for treatment for longitudinal monitoring of NT1 patients. * Patient speaking and understanding French. * The patient must have given their free and informed consent and signed the consent form or consent has been provided from the holder(s) of parental authority or the legal guardian and the child. * The patient must be a member or beneficiary of a health insurance plan Inclusion criteria for control subjects: • Absence of diagnosis of sleep disorder responsible for hypersomnolence with an Epworth sleepiness scale score greater than 10/24. Exclusion Criteria: * Subject having presented an infectious pathology requiring antibiotic treatment in the previous 3 months. * Subject with a dysimmune pathology. * Subject having had treatment with an immunomodulatory molecule or chemotherapy within 60 days before inclusion in the research or whose indication is planned for the duration of the research. * Subject with a chronic digestive pathology or having undergone bariatric surgery in the previous year. * Subject on laxative. * Subject living in a medical institution. * Subject under legal protection, guardianship or curatorship. * Subject and/or their legal representative (if a minor patient) unable to express consent * Taking antibiotics during the inclusion period, or laxative or any other treatment having a significant impact on the microbiota
Where this trial is running
Nîmes, Gard and 1 other locations
- Nîmes University Hospital — Nîmes, Gard, France (Not_yet_recruiting)
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Catherine Dunyach-Remy — CHU de Nimes
- Study coordinator: Catherine Dunyach-Remy
- Email: catherine.remy@chu-nimes.fr
- Phone: 0466683202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.