Narcolepsy Type 1NARCOBIOTENCT06292598
Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population
An observational study of Narcolepsy Type 1 and Bacterial Translocation, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy Type 1, Bacterial Translocation
- What is being tested?
- Blood sample, Stool sample and CSF sample
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Mar 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
- Absence of diagnosis of sleep disorder responsible for hypersomnolence with an Epworth sleepiness scale score greater than 10/24.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier
Yves DAUVILLIERS, y-dauvilliers@chu-montpellier.fr
Yves DAUVILLIERS
- Not yet recruiting
Nîmes University Hospital
Nîmes, Gard, 30029
Anissa MEGZARI, +33 4 66 68 42 36, drc@chu-nimes.fr
Catherine DUNYACH-REMY
About this study
Official title: Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients
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.
Read more
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.
- Conditions
- Narcolepsy Type 1, Bacterial Translocation
- Being tested
- Blood sample, Stool sample, CSF sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Sample taken to test plasma permeability markers
Stool sampleOther
Sample taken to test microbial diversity and composition
CSF sampleOther
Sample taken to test orexin level
| Study group | Role | What they receive |
|---|---|---|
| Patients with untreated NT1 | Not described Receives: Other: Blood sample; Other: Stool sample; Other: CSF sample | |
| Matched controls | Controls matched on sex, age (+/- 2 years) and BMI class (BMI < 25: normal; 25 ≤ BMI ≤ 30: overweight; BMI > 30: obesity) Receives: Other: Blood sample; Other: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma bacterial translocation profiles between groups
Circulating plasma r16s DNA (copies/μL)
Measured: Day 0
Secondary outcomes (24)
Plasma bacterial translocation profiles in NT1 patients
Circulating plasma r16s DNA (copies/μL)
Measured: Month 12
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)
Measured: Day 0
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 (%)
Measured: Day 0
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 (%)
Measured: Month 12
Beta diversity of the intestinal microbiota between groups
measured by metabarcoding
Measured: Day 0
Beta diversity of the intestinal microbiota in NT1 patients
measured by metabarcoding
Measured: Month 12
Alpha diversity of the intestinal microbiota between groups
measured by metabarcoding
Measured: Day 0
Alpha diversity of the intestinal microbiota in NT1 patients
measured by metabarcoding
Measured: Month 12
Composition of the intestinal microbiota between groups
Relative abundance of bacterial phyla and genera (%) measured by metabarcoding
Measured: Day 0
Composition of the intestinal microbiota between groups
Relative abundance of bacterial phyla and genera (%) measured by metabarcoding
Measured: Month 12
Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile between groups
Measured by ELISA (pg/mL)
Measured: Day 0
Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile in NT1 patients
Measured by ELISA (pg/mL)
Measured: Month 12
Plasma LPS-binding Protein (LBP) profile between groups
Measured by ELISA (μg/mL
Measured: Day 0
Plasma LPS-binding Protein (LBP) profile in NT1 patients
Measured by ELISA (μg/mL
Measured: Month 12
Plasma Soluble CD14 profile between groups
Measured by ELISA (μg/mL
Measured: Day 0
Plasma Soluble CD14 profile in NT1 patients
Measured by ELISA (μg/mL
Measured: Month 12
Age of onset of symptoms in NT1 patients
Years
Measured: Day 0
Duration of disease progression in NT1 patients
Years
Measured: Day 0
Severity of sleep-related symptoms in NT1 patients
Epworth scale
Measured: Day 0
Severity of narcolepsy symptoms in NT1 patients
Narcolepsy Severity Scale
Measured: Day 0
Description of comorbidities in NT1 patients
List
Measured: Day 0
Sleep onset latency in NT1 patients
Minutes
Measured: Day 0
Number of rapid eye movement sleep episodes in NT1 patients
Number
Measured: Day 0
Orexin levels in CSF in NT1 patients
Measured by Radio-immuno-assay (pg/ml)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start10 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Dunyach-Remy, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292598
- Sponsor's protocol ID
- AOI2022/2023/CDR-01
- Acronym
- NARCOBIOTE
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients
- ClinicalTrials.gov ID
- NCT06292598
- Acronym / sponsor ID
- NARCOBIOTE / AOI2022/2023/CDR-01
- Conditions
- Narcolepsy Type 1, Bacterial Translocation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with untreated NT1 | – | Other: Blood sample, Other: Stool sample, Other: CSF sample |
| Matched controls | – | Other: Blood sample, Other: Stool sampleControls matched on sex, age (+/- 2 years) and BMI class (BMI < 25: normal; 25 ≤ BMI ≤ 30: overweight; BMI > 30: obesity) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleSample taken to test plasma permeability markers | Other | Matched controls, Patients with untreated NT1 |
| Stool sampleSample taken to test microbial diversity and composition | Other | Matched controls, Patients with untreated NT1 |
| CSF sampleSample taken to test orexin level | Other | Patients with untreated NT1 |
Primary outcome
Plasma bacterial translocation profiles between groups
Time frame: Day 0
Circulating plasma r16s DNA (copies/μL)
24 secondary outcomes
Plasma bacterial translocation profiles in NT1 patients
Time frame: Month 12
Taxonomic characteristics of DNA in the CSF of NT1 patients according to narcolepsy severity
Time frame: Day 0
Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation
Time frame: Day 0
Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation
Time frame: Month 12
Beta diversity of the intestinal microbiota between groups
Time frame: Day 0
Beta diversity of the intestinal microbiota in NT1 patients
Time frame: Month 12
Alpha diversity of the intestinal microbiota between groups
Time frame: Day 0
Alpha diversity of the intestinal microbiota in NT1 patients
Time frame: Month 12
Composition of the intestinal microbiota between groups
Time frame: Day 0
Composition of the intestinal microbiota between groups
Time frame: Month 12
Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile between groups
Time frame: Day 0
Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile in NT1 patients
Time frame: Month 12
Plasma LPS-binding Protein (LBP) profile between groups
Time frame: Day 0
Plasma LPS-binding Protein (LBP) profile in NT1 patients
Time frame: Month 12
Plasma Soluble CD14 profile between groups
Time frame: Day 0
Plasma Soluble CD14 profile in NT1 patients
Time frame: Month 12
Age of onset of symptoms in NT1 patients
Time frame: Day 0
Duration of disease progression in NT1 patients
Time frame: Day 0
Severity of sleep-related symptoms in NT1 patients
Time frame: Day 0
Severity of narcolepsy symptoms in NT1 patients
Time frame: Day 0
Description of comorbidities in NT1 patients
Time frame: Day 0
Sleep onset latency in NT1 patients
Time frame: Day 0
Number of rapid eye movement sleep episodes in NT1 patients
Time frame: Day 0
Orexin levels in CSF in NT1 patients
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Dunyach-Remy principal investigator
CHU de Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy Type 1 and Bacterial Translocation, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Dunyach-Remy (0466683202, catherine.remy@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma bacterial translocation profiles between groups (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.