Motor Neurone Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

If you have ALS (with or without frontotemporal dementia symptoms):

• You are 18 years of age or older
• You have been diagnosed with ALS using a standard set of medical criteria
• Your muscle weakness or speech problems began no more than 24 months before joining the study
• Your ALS functioning score and breathing capacity are above certain minimum levels at your initial screening (confirm with trial site)
• You have a caregiver or close contact who knows you well enough to answer questions about your thinking and behaviour
• You are able to understand and sign a consent form
• If you could become pregnant, you have a negative pregnancy test at screening and agree to use an approved form of birth control throughout the study (including abstinence, hormonal contraceptives, double-barrier methods, intrauterine devices, or a partner who has had a vasectomy for at least 6 months)
• You are willing to keep your eating habits the same throughout the study
• You are willing to stop taking probiotic supplements and avoid foods with added probiotics or prebiotics (such as yogurts with live cultures) from screening until the end of the study

If you are a healthy volunteer:

• You are 18 years of age or older
• You are able to understand and willing to sign a consent form
• If you could become pregnant, you have a negative pregnancy test at screening and agree to use an approved form of birth control throughout the study
• You are willing to keep your eating habits the same throughout the study
• You are willing to avoid probiotic supplements and foods with added probiotics or prebiotics from the start of the study until it ends

If you are a caregiver or informant:

• You are 18 years of age or older
• You have regular and close enough contact with the patient to accurately describe their thinking abilities and behaviour
• You are able to understand and willing to sign a consent form

Who may not be able to join:

If you have ALS:

• You are currently using a breathing machine or breathing support device
• You have a serious medical condition or behavioural issue that the study doctor believes could interfere with your participation
• You are currently using a feeding tube
• You have been taking cholesterol-lowering medication for less than 3 months before joining, or you recently started one (unless it was prescribed due to a heart attack or stroke)
• You have been taking the ALS medication edaravone at a stable dose for less than 2 months, or riluzole at a stable dose for less than 1 month before joining
• You start taking edaravone or riluzole during the trial
• You have a weakened immune system (for example, due to HIV/AIDS, lymphoma, long-term steroid use, chemotherapy, or an organ transplant)
• You are currently pregnant, planning to become pregnant, or breastfeeding
• You have taken probiotic supplements in the month before joining (though you may be eligible after a 4-week break)
• You have taken antibiotics in the month before joining (though you may be eligible after a 4-week break)
• You have a milk or soy allergy, or severe lactose intolerance
• You are currently taking part in another clinical trial

If you are a healthy volunteer:

• You have been taking cholesterol-lowering medication for less than 3 months, or recently started one (unless due to a heart attack or stroke)
• You are currently pregnant, planning to become pregnant, or breastfeeding
• You have taken probiotic supplements in the month before the study starts (though you may be eligible after a 4-week break)
• You have taken antibiotics in the month before the study starts (though you may be eligible after a 4-week break)
• You have a milk or soy allergy, or severe lactose intolerance
• You are currently taking part in another clinical trial

Important: Always verify eligibility with the trial site directly before applying.