Longitudinal Assessment of the Gut Microbiome in People with ALS

Study Purpose:

In this research study we are looking at the stool of people with amyotrophic lateral sclerosis (ALS) to observe the relationship between the gut microbiome and the progression of ALS over time.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

James D. Berry, MD MPH (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

No

Coordinating Center Contact Information

Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital
Kelly Fisher / .(JavaScript must be enabled to view this email address) / 617-726-9094
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Suite 600
Boston, Massachusetts 02035 United States

Full Study Summary:

This study is recruiting participants with ALS, asymptomatic patients who carry an ALS causing gene, and healthy volunteers. The purpose of the research study is to look at the stool of people with ALS to observe the relationship between the gut microbiome and the progression of ALS over time. Information collected in this study through questionnaires regarding medical history and diet, as well as stool and blood samples will further our understanding of ALS and contribute towards the development of novel therapeutics. ALS and healthy volunteers will have visits every 3 months, while asymptomatic ALS gene carriers will have visits every 6 months. Visits may be attended in-person or remotely, over a span of 5 years.

Study Sponsor:

National Institutes of Health and Brigham and Women’s Hospital, Inc.

Participant Duration:

Each participant will be enrolled in the study for 5 years. ALS participants and healthy volunteers will have visits every 3 months, while asymptomatic ALS gene carriers will have visits every 6 months. Visits may be attended in-person or entirely remotely.

Estimated Enrollment:

500

Estimated Study Start Date:

11/01/2021

Estimated Study Completion Date:

Posting Last Modified Date:

05/02/2022

Date Study Added to alsconsortium.org:

05/02/2022
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    No use of gastrostomy tube for feeding at time of enrollment. No known diagnosis of inflammatory bowel disease, irritable bowel syndrome, colon cancer, or other active gastrointestinal disease requiring current treatment, excluding gastroesophageal reflux disease or chronic constipation.

  • Site Contact Information

    Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital
    Kelly Fisher / .(JavaScript must be enabled to view this email address) / 617-726-9094
    165 Cambridge Street
    Boston, Massachusetts 02035
    United States