Gut bacteria linked to narcolepsy? new study investigates

NCT ID NCT06292598

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether changes in gut bacteria and increased intestinal permeability can trigger inflammation that damages brain cells in people with type 1 narcolepsy. Researchers will collect blood, stool, and spinal fluid samples from 120 participants to measure bacterial DNA and immune markers. The goal is to understand the role of gut health in this rare sleep disorder.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this study could reveal how gut bacteria contribute to narcolepsy, pointing toward new ways to diagnose or treat the condition.
What could go wrong: This is an observational study, not a treatment trial. It may not find a clear link, and results may not lead to immediate therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bacterial translocation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

narcolepsy-cataplexy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacterial translocation Narcolepsy type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Gut bacteria linked to narcolepsy? new study investigates

What the study statuses mean