Trial News & Events

Longitudinal Assessment of the Gut Microbiome in People with ALS

The Neurological Clinical Research Institute at Massachusetts General Hospital is seeking individuals to participate in a Longitudinal Assessment of the Gut Microbiome in People with ALS research study currently enrolling under the direction of Dr. James Berry.

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.

Major inclusion criteria include:

  • 18 years of age or older
  • ALS Subjects Only: Diagnosis of familial or sporadic ALS or individuals with known gene mutations associated with ALS (regardless of clinical phenotype) per self-report.
  • Control Subjects Only: Absence of known diagnosis of ALS, or known ALS causative gene

Major exclusion criteria include:

  • 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.
  • Inability to comply with study procedures in the view of the investigator

If you are interested in learning more about the study, please contact the study coordinator, Kelly Fisher at (617) 726-9094 or by e-mail at kefisher@mgh.harvard.edu.