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.

Study Status:

Recruiting

Disease:

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

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

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

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

Clinicaltrials.gov ID:

Neals Affiliated?

No

Coordinating Center Contact Information

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

Posting Last Modified Date:

12 / 01 / 2022

Date Study Added to neals.org:

05 / 02 / 2022