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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 10, 2025

Keywords

ClinConnect Summary

The ALS-Gut study is a research project aimed at understanding the gut microbiota, which is the community of bacteria living in our intestines, in patients with amyotrophic lateral sclerosis (ALS). ALS is a serious disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and paralysis. Researchers believe that changes in the gut microbiota might play a role in the disease's progression, so this study will analyze the gut bacteria of 300 ALS patients in France to see how it differs from healthy individuals. By doing this, they hope to find connections between the gut microbiota and the characteristics of ALS, which could lead to new treatment options that might help slow down muscle decline.

To participate in this study, individuals must be at least 18 years old and diagnosed with ALS according to specific medical guidelines. Participants will be recruited from 18 specialized ALS centers in France, and they will need to give consent for their health data to be collected. Those who join will provide a stool sample to help researchers study their gut bacteria. This is an exciting opportunity for ALS patients to contribute to important research that could improve understanding and treatment of the disease in the future.

Gender

ALL

Eligibility criteria

• Common inclusion criteria :
• • 1. 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).
• • 2. Follow-up in one of the 18 French ALS expert centers participating in the study.
• • 3. Age ≥18 years
• • 4. Social security affiliation or beneficiary
• • 5. Informed of the ALS-Gut study and not objecting to the collection of his/her data
• Common non-inclusion criteria:
• • 1. Other concomitant neurodegenerative pathology
• • 2. 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
• Inclusion criteria specific to patients not included in the French Gut study :
• • 1. 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.
• Specific non-inclusion criteria for patients not included in the French Gut (criteria linked to the French Gut) :
• • 1. Person not living in France
• • 2. Person who has had a colectomy (declarative) ;
• • 3. Person with a digestive stoma (declarative);
• • 4. Colonoscopy performed in the 3 months prior to inclusion (declarative).
• • 5. Antibiotics taken in the 3 months prior to inclusion (self-reported);
• • Secondary exclusion criteria specific to patients included in the ALS-Gut study prior to inclusion in French Gut
• • 1. No response to the French Gut entry questionnaire
• • 2. Failure to send a compliant stool sample
• • 3. Person who has not signed a French Gut consent form