protocolSection identificationModule nctId: NCT06292598, orgStudyIdInfo id: AOI2022/2023/CDR-01, briefTitle: Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population, acronym: NARCOBIOTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: Narcolepsy type 1 (NT1) is a rare disease characterized by severe drowsiness, cataplexy, hypnagogic hallucinations, sleep paralysis, poor night sleep, and often obesity. NT1 is caused by irreversible loss of orexin (ORX)/hypocretin neurons in the lateral hypothalamus with decreased ORX levels in the cerebrospinal fluid (CSF). Although the underlying process leading to this destruction remains unclear; an autoimmune origin is suspected.The study authors recently compared the bacterial communities of the fecal microbiota of NT1 patients and control subjects. Initial results demonstrated a difference in overall bacterial community structure in NT1 compared to controls, as assessed by beta diversity, even after adjusting for body mass index (BMI). The Shannon biodiversity index was also correlated with the duration of NT1 disease. However, no association was found between the structure of the microbial community and the clinical characteristics of NT1 patients.In 2022, a second study from the SOMNOBANK cohort on a larger population confirmed these results, showing dysbiosis between NT1 patients and the control population. The altered intestinal microbial diversity supports the important role of the environment in the development and pathogenesis of NT1. Other studies have established a link between dysbiosis, intestinal permeability and inflammation in other neuroimmune pathologies. Currently, no study has focused on these phenomena of bacterial translocation, intestinal permeability and immune activation linked to the microbiota in type 1 narcolepsy patients.The study hypothesis is that NT1 patients with dysbiosis in their intestinal microbiota also present a bacterial translocation with an intestinal origin, leading to a systemic inflammatory syndrome favoring an autoimmune damage destroying hypocretin neurons in the hypothalamus. The study authors suspect that microbial elements (DNA) involved in the autoimmune process could be detected in the CSF. This bacterial translocation could vary over time depending on: i) the progression of the disease and its management; ii) changing dysbiosis and: iii) the increase in intestinal permeability and inflammation., conditionsModule conditions: Narcolepsy Type 1, conditions: Bacterial Translocation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, interventions name: Stool sample, interventions name: CSF sample, outcomesModule primaryOutcomes measure: Plasma bacterial translocation profiles between groups, secondaryOutcomes measure: Plasma bacterial translocation profiles in NT1 patients, secondaryOutcomes measure: Taxonomic characteristics of DNA in the CSF of NT1 patients according to narcolepsy severity, secondaryOutcomes measure: Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation, secondaryOutcomes measure: Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation, secondaryOutcomes measure: Beta diversity of the intestinal microbiota between groups, secondaryOutcomes measure: Beta diversity of the intestinal microbiota in NT1 patients, secondaryOutcomes measure: Alpha diversity of the intestinal microbiota between groups, secondaryOutcomes measure: Alpha diversity of the intestinal microbiota in NT1 patients, secondaryOutcomes measure: Composition of the intestinal microbiota between groups, secondaryOutcomes measure: Composition of the intestinal microbiota between groups, secondaryOutcomes measure: Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile between groups, secondaryOutcomes measure: Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile in NT1 patients, secondaryOutcomes measure: Plasma LPS-binding Protein (LBP) profile between groups, secondaryOutcomes measure: Plasma LPS-binding Protein (LBP) profile in NT1 patients, secondaryOutcomes measure: Plasma Soluble CD14 profile between groups, secondaryOutcomes measure: Plasma Soluble CD14 profile in NT1 patients, secondaryOutcomes measure: Age of onset of symptoms in NT1 patients, secondaryOutcomes measure: Duration of disease progression in NT1 patients, secondaryOutcomes measure: Severity of sleep-related symptoms in NT1 patients, secondaryOutcomes measure: Severity of narcolepsy symptoms in NT1 patients, secondaryOutcomes measure: Description of comorbidities in NT1 patients, secondaryOutcomes measure: Sleep onset latency in NT1 patients, secondaryOutcomes measure: Number of rapid eye movement sleep episodes in NT1 patients, secondaryOutcomes measure: Orexin levels in CSF in NT1 patients, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nîmes University Hospital, city: Nîmes, state: Gard, zip: 30029, country: France, contacts name: Anissa MEGZARI, role: CONTACT, phone: +33 4 66 68 42 36, email: drc@chu-nimes.fr, contacts name: Catherine DUNYACH-REMY, role: PRINCIPAL_INVESTIGATOR, contacts name: Jean-Philippe LAVIGNE, role: SUB_INVESTIGATOR, contacts name: Béatrix ABRIL, role: SUB_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, locations facility: Centre Hospitalier Universitaire de Montpellier, city: Montpellier, country: France, contacts name: Yves DAUVILLIERS, role: CONTACT, email: y-dauvilliers@chu-montpellier.fr, contacts name: Yves DAUVILLIERS, role: PRINCIPAL_INVESTIGATOR, contacts name: Lucie BARATEAU, role: SUB_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False