Metagenomic Characterization of the Intestinal Microbiota in ALS Patients and Association With Clinical Phenotypes

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06771414
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • data collection — OTHER
    data collection

Study Details

"Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease involving motor neurons in the cerebral cortex, brain stem and spinal cord. Loss of functional motor neurons is responsible for rapid progressive muscle paralysis, generally leading to death from respiratory failure within 3 to 5 years. Data obtained in mouse models of the disease suggest that changes in the intestinal microbiota may be involved in the pathophysiology of the disease. However, to date, there are no solid data on the existence of intestinal dysbiosis in ALS patients and its prognostic influence. The ALS-Gut study will make it possible for the first time to quantitatively and qualitatively characterize the gut microbiota in a large population of French ALS patients, and to identify changes associated with the disease compared with healthy subjects. It will also identify possible associations between observed deviations in microbiota and the ALS phenotype, its management modalities, and its evolutionary profile. This study will thus pave the way for innovative therapeutic strategies aimed at re-establishing a favorable gut microbiota profile, in order to limit the progression of motor impairment. The aim of the ALS-Gut study is to quantitatively and qualitatively characterize the microbiota in a cohort of 300 French ALS patients, and to correlate these results with the clinical features of the disease. The ALS-Gut study will be based on the "Le French Gut" project carried out by a consortium comprising INRAE, AP-HP, INSERM and Institut Pasteur on 100,000 volunteers, aimed at characterizing the heterogeneity and diversity of the intestinal microbiota of subjects living in France. The ALS-Gut study is a non-human research study, which will use clinical data collected prospectively in 18 French ALS expert centers as part of the routine management of 300 French ALS patients participating in the "Le French Gut" project."

Key Dates

Start date
Mar 31, 2026
Status verified
Dec 2024
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

characterize the intestinal microbiota of French ALS patients [ Time Frame: Day 0 ]

Central Contacts

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