Microbiome Assessment in People with ALS (MAP ALS)

Study Purpose:

The purpose of the research study is to collect stool samples from people with amyotrophic lateral sclerosis (ALS) and healthy volunteers. Through comparison of these samples, the researchers hope to learn more about the microbiome (i.e. bacterial strains) in the stool of patients with ALS, as well as find unique biological markers, which could be used to develop new therapies.

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:

Not enrolling

Phase:

Not Applicable

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

Katharine Nicholson, MD, Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital
Maryangel Jeon / .(JavaScript must be enabled to view this email address) / 617-724-9196
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Boston, Massachusetts 02114 United States

Full Study Summary:

We will collect stool samples from people with ALS and compare these to samples collected from people without ALS. Samples will be sent to the Broad Institute for analysis.

Study Sponsor:

ALS Finding a Cure

Participant Duration:

All eligible subjects will provide clinical information and participate in a one-time stool collection. ALS subjects will have the option to participate in up to 2 additional brief visits collecting only clinical information, 3 months and 6 months after the first visit.

Estimated Enrollment:

100 with ALS & 100 Controls

Estimated Study Start Date:

12/31/2015

Estimated Study Completion Date:

11/02/2016

Posting Last Modified Date:

01/11/2018

Date Study Added to alsconsortium.org:

01/19/2016

Eligibility Criteria

Gender:
Female, Male
Minimum Age:
18
Maximum Age:
N/A

Time since Symptom Onset:

Time since Diagnosis:

Can participants use Riluzole?
Yes

You must be at least 18 years of age, answer brief questions about your medical and family history, and give a stool samples.
Site Contact Information

Massachusetts General Hospital
Boston, Massachusetts 02114
United States