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

NCT06771414 | Not Yet Recruiting

• 1 other identifier: APHP241702
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

"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."

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; Amyotrophic Lateral Sclerosis; microbiota; gut microbiota; french gut

Outcome Measures

Primary Outcomes (1)

• characterize the intestinal microbiota of French ALS patients

  description of the presence and abundance in the samples of each of the 10.4 million gut microbial genes listed in the IGC2 (Integrated Gene Catalog 2) catalog

  Day 0

Interventions

data collection OTHER

data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ALS

You may qualify if:

• Patient with ALS that is possible, probable with the support of complementary examinations, clinically probable or defined according to the revised El Escorial diagnostic criteria (Brooks, et al. 2000).
• Follow-up in one of the 18 French ALS expert centers participating in the study.
• Age ≥18 years
• Social security affiliation or beneficiary
• Informed of the ALS-Gut study and not objecting to the collection of his/her data
• Other concomitant neurodegenerative pathology
• Persons subject to a protective measure, notably guardianship or trusteeship, or unable to express their consent.
• PATIENTS ALREADY INCLUDED IN FRENCH GUT 1. Patient agrees to provide French Gut with his or her participation number.
• PATIENTS NOT YET INCLUDED IN FRENCH GUT
• \. Patient agreeing to take part in the French Gut project, i.e. registering on his or her own initiative, on the project's dedicated website (https://lefrenchgut.fr/) and completing a detailed questionnaire. Then, on receipt of the stool sampling kit at home, return the stool sample to INRAE.
• Person not living in France
• Person who has had a colectomy (declarative) ;
• Person with a digestive stoma (declarative);

You may not qualify if:

• No response to the French Gut entry questionnaire
• Failure to send a compliant stool sample
• Person who has not signed a French Gut consent form

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• ARSLA: collaborator
• ALS Association: collaborator
• Filière FilSLAN: collaborator

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Gaëlle Pr Bruteneau

CONTACT

01 42 16 24 72; gaelle.bruneteau@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 13, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.