BIOMAX-ALS
Research type
Research Study
Full title
A study to establish and modulate the relationship between the microbiome-microglia axis in ALS: an observational study with a subsequent randomised, double-blind, placebo-controlled, faecal microbiota transplant intervention (BIOMAX-ALS)
IRAS ID
226746
Contact name
Nikhil Sharma
Contact email
Sponsor organisation
University College London
Eudract number
2017-004841-26
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Nerves in our brain and spinal cord control how our muscles work. These are called motor neurones. Motor Neurone Disease (MND) is a progressive neurodegenerative disease that attacks the motor neurones. Symptoms of MND can include loss of mobility, and difficulties with speech, swallowing and breathing.
There is no cure for the MND. On average, MND kills a third of people within a year and more than half within two years of diagnosis.
Finding a way to slow down the progression of MND is critical. This work will explore a recently discovered link between the microbes in the gut and inflammation in the brain (labelled the microbiome-microglia axis).
In animals, the gut microbes influence the cells in the brain that control inflammation. We call these cells microglia. The microglia are central in MND and other diseases like Alzheimer’s disease. We suspect the microglia may be able to protect the motor neurones early in MND. If this is the case, then it will open up new areas of research.
This research project is in two parallel parts:
i. the main study including an observational period with MND patients and healthy controls, followed by an intervention to influence gut microbiota to see if we can alter microglia function in MND patients.
ii. An observational substudy in a larger group of MND patients to gather longitudinal data on the microbiome and its relationship to disease progression.The study will use brain scans, brain stimulation, muscle ultrasound, and microbiome analysis as well as a host of behavioural measures to shed light on the ‘microbiome-microglia axis’ and its role in disease progression.
The potential impact of the work is broad. Not only would it open up new potential treatments for MND but it could help with other diseases like Alzheimer’s disease.
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0071
Date of REC Opinion
28 Feb 2022
REC opinion
Further Information Favourable Opinion