NCT06771414Not yet recruiting
Metagenomic Characterization of the Intestinal Microbiota in ALS Patients and Association With Clinical Phenotypes
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
"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."
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- Mar 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06771414
What you commit to
- Study type: Observational
- Planned participants: 300
- From Mar 2026 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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) :
- Person not living in France
- Person who has had a colectomy (declarative) ;
- Person with a digestive stoma (declarative);
- Colonoscopy performed in the 3 months prior to inclusion (declarative).
- 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
- 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
Criteria the registry did not label
- Common inclusion criteria :
- 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
- Common non-inclusion criteria:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.