Actively Recruiting

Age: 10Years +
All Genders
Healthy Volunteers
ID06292598

Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients

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

120

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Narcolepsy type 1 (NT1) is a rare condition marked by extreme drowsiness, cataplexy, 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 suspected autoimmune causes. Previous research showed differences in gut bacterial communities between NT1 patients and healthy controls, suggesting a role for gut bacteria and inflammation in NT1 development. However, the link between bacterial translocation, intestinal permeability, and immune activation in NT1 has not yet been studied. This research compares gut bacteria and bacterial translocation in NT1 patients and matched controls based on sex, age, and body mass index. Samples of blood, stool, and cerebrospinal fluid (CSF) will be collected to assess microbial diversity, bacterial DNA presence, plasma markers of intestinal permeability, and orexin levels in the CSF. The study aims to identify bacterial elements in the CSF that may contribute to autoimmune damage and track these factors over time. Participants will have their plasma bacterial translocation profiles measured at the beginning and after 12 months. Intestinal microbiota diversity and composition, plasma inflammation markers, and narcolepsy symptom severity will also be evaluated at these times. The study involves detailed assessments including sleep measurements and clinical evaluations. Participants will be monitored for up to 12 months to understand how gut bacteria and immune factors relate to NT1 progression.

CONDITIONS

Brief 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 given by guardian
  • Patient is a member or beneficiary of a health insurance plan
  • Control subjects must have no sleep disorder causing hypersomnolence and Epworth sleepiness scale score ≤ 10/24
Not Eligible

You will not qualify if you...

  • Infectious disease requiring antibiotics in the past 3 months
  • Dysimmune pathology
  • Treatment with immunomodulatory drugs or chemotherapy within 60 days before inclusion or planned during research
  • Chronic digestive disease or bariatric surgery in the past year
  • Use of laxatives
  • Living in a medical institution
  • Under legal protection, guardianship, or curatorship
  • Unable to give consent or legal guardian unable to consent
  • Taking antibiotics, laxatives, or other treatments significantly impacting microbiota during inclusion period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants provide blood, stool, and CSF samples to assess bacterial translocation, gut microbiota, and orexin levels.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are monitored over 12 months to evaluate changes in bacterial translocation profiles and gut microbiota characteristics.

1 visit at Month 12 (in-person)

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

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