Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adults or children (≥10 years) with type 1 narcolepsy managed at the Montpellier and Nîmes teaching hospitals. This population will be matched on sex, age (± 2 years) and BMI class (BMI \< 25: normal; 25 ≤ BMI ≤ 30: overweight; BMI \> 30: obese) with a population of control subjects without central hypersomnolence, consulting the participating services mainly for another sleep disorder.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Other intervention

    Sample taken to test plasma permeability markers

  • Stool sample

    Other intervention

    Sample taken to test microbial diversity and composition

  • CSF sample

    Other intervention

    Sample taken to test orexin level

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Patients with untreated NT13 interventions
Group B: Matched controls2 interventions

Trial outcomes

Primary outcomes

1

Plasma bacterial translocation profiles between groups

Circulating plasma r16s DNA (copies/μL)

Time frame
Day 0

Secondary outcomes

1

Plasma bacterial translocation profiles in NT1 patients

Circulating plasma r16s DNA (copies/μL)

Time frame
Month 12
2

Taxonomic characteristics of DNA in the CSF of NT1 patients according to narcolepsy severity

Metagenomic sequencing of all genomes present, compared with international databases, presented as number of reads per species (bacterial, fungal and viral)

Time frame
Day 0
3

Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation

Metabarcoding of 16srDNA of bacterial DNA present in plasma in NT1 patients with 16S rDNA \>25 copies/μL, presented as relative abundance of bacterial phyla and genera (%)

Time frame
Day 0
4

Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation

Metabarcoding of 16srDNA of bacterial DNA present in plasma in NT1 patients with 16S rDNA \>25 copies/μL, presented as relative abundance of bacterial phyla and genera (%)

Time frame
Month 12

Other outcomes

Sponsors and contacts

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