Gut bacteria and bacterial translocation in people with type 1 narcolepsy versus controls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Universitaire de Montpellier
  Montpellier, France Recruiting
• Nîmes University Hospital
  Nîmes, Gard, France Not yet recruiting

Study contacts

• Principal investigator: Catherine Dunyach-Remy — CHU de Nimes
• Study coordinator: Catherine Dunyach-Remy
• Email: catherine.remy@chu-nimes.fr
• Phone: 0466683202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.