Bacterial Translocation & Gut Microbiota in Type 1 Narcolepsy Patients

Status Not yet recruiting

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06292598
Study type	Observational
Source	Centre Hospitalier Universitaire de Nimes
Contact	Catherine Dunyach-Remy
Phone	0466683202
Email	catherine.remy@chu-nimes.fr
Status	Not yet recruiting
Phase
Start date	May 2024
Completion date	May 2027

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See also
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Completed	`NCT05687903` - A Study of TAK-861 in Participants With Narcolepsy Type 1	Phase 2
Recruiting	`NCT05967832` - Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy	N/A
Not yet recruiting	`NCT05914194` - A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1	Phase 3
Active, not recruiting	`NCT05709873` - Narcolepsy Nightmare Study	N/A
Recruiting	`NCT04483310` - Meditation-Relaxation (MR Therapy) for Sleep Paralysis.	N/A
Completed	`NCT04445129` - Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
Completed	`NCT05460052` - Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
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Recruiting	`NCT05816382` - A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions	Phase 2/Phase 3
Not yet recruiting	`NCT06336057` - Mentalizating in Adults Suffering From Narcolepsy Type 1.
Recruiting	`NCT06251063` - Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence	N/A
Completed	`NCT06241911` - Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms