Biomarkers for risk assessment, diagnosis and target microbiome and intestinal homeostasis for prevention and treatment of amyotrophic lateral sclerosis

A method of identifying an asymptomatic subject for stratification into an amyotrophic lateral sclerosis (ALS) treatment regime, the method comprising:

• obtaining a biological sample from the subject, wherein the sample is obtained from the subject's gastrointestinal tract;
• a) measuring a level of a microbial population and detecting whether there is a change in the microbial population in the gastrointestinal tract relative to a control subject;
• b) measuring a level of a microbial marker and detecting whether there is a change in the microbial marker in the gastrointestinal tract relative to a control subject;
• c) measuring a level of a tight junction marker and detecting whether there is a loss of structure and function in the gastrointestinal tract relative to a control subject;
• and
• d) measuring a level of a Paneth cell defect and detecting whether there is a change in a number of Paneth cells/crypt or a change in a number of abnormal cells in the gastrointestinal tract relative to a control subject;
• and
• identifying the subject having each of the decrease in a), the decrease in b), the loss of structure and function in c) and the decrease in the number of Paneth cells/crypt or the increase in the number of abnormal cells in d).