Actively Recruiting

Age: 10Years +
All Genders
Healthy Volunteers
ID06292598

Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Compared to Controls An Observational Study to Explore Microbial and Immune Factors in Narcolepsy

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-11-17

120

Participants Needed

2

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Narcolepsy type 1 (NT1) is a rare condition marked by excessive sleepiness, sudden muscle weakness (cataplexy), vivid hallucinations at sleep onset, sleep paralysis, poor nighttime sleep, and often obesity. It results from irreversible loss of orexin-producing neurons in the brain, with decreased orexin levels in cerebrospinal fluid. The cause is unclear but may involve autoimmune processes. Previous research showed differences in gut bacteria between NT1 patients and controls, linking altered gut microbiota to NT1 and suggesting a role of environmental factors in disease development. This research evaluates the presence of bacterial translocation from the gut into the body in NT1 patients compared to controls. Participants provide blood samples to test plasma permeability markers, stool samples to analyze gut microbial diversity, and cerebrospinal fluid (CSF) samples to measure orexin levels and detect bacterial DNA. These samples help study the relationship between gut bacteria imbalance, intestinal permeability, inflammation, and immune activation in NT1. Participants undergo assessments at study entry to measure bacterial translocation profiles in plasma. Researchers monitor gut microbiota diversity and inflammation markers, as well as orexin levels in CSF. The study tracks how bacterial translocation and related immune responses may change with disease progression and treatment. Participants' informed consent is required, and safety and health insurance status are ensured. This study aims to deepen understanding of NT1's underlying causes by exploring gut-brain interactions over time.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient diagnosed with narcolepsy type 1 (NT1).
  • Patient not treated for narcolepsy during initial evaluation.
  • Patient eligible for treatment for longitudinal monitoring.
  • Patient speaks and understands French.
  • Patient has given free and informed consent or consent provided by legal guardian.
  • Patient is member or beneficiary of a health insurance plan.
  • Control subjects must not have sleep disorders causing excessive sleepiness with Epworth sleepiness scale score above 10/24.
Not Eligible

You will not qualify if you...

  • Infection requiring antibiotic treatment in the previous 3 months.
  • Presence of dysimmune pathology.
  • Treatment with immunomodulatory drugs or chemotherapy within 60 days before inclusion or planned during the study.
  • Chronic digestive disease or bariatric surgery within the past year.
  • Use of laxatives.
  • Living in a medical institution.
  • Under legal protection, guardianship, or curatorship.
  • Unable to provide consent or legal representative unable to consent.
  • Taking antibiotics, laxatives, or other treatments impacting microbiota during inclusion period.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nîmes University Hospital

Nîmes, Gard, France, 30029

Not Yet Recruiting

2

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Actively Recruiting

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Research Team

C

Catherine Dunyach-Remy

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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