Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients

Inclusion Criteria

• •ALS participants:
• •1. Aged 18 years old or greater.
• •2. Diagnosis of ALS by El Escorial Criteria revised (possible, probable, probable with lab support and definite).
• •3. Onset of weakness or speech impairment no more than 24 months before randomization.
• •4. ALSFRS-R equal or superior to 24/48 at screening, with no more than one subscore under 2/4. ALSFRS-R slope of decline of at least 0.5 points per month on the ALSFRS- R, calculated as (48-score at screening)/ (months since onset of weakness).
• •5. SVC greater than or equal to 60% predicted for sex, age and height at screening.
• •6. Note on FTD Symptoms: The presence of FTD symptoms is not a requirement for inclusion in this study. Participants with a diagnosis of ALS, whether or not accompanied by FTD symptoms, are eligible for inclusion. No prior or screening diagnosis of FTDSD is required.
• •7. Subject has an informant/caregiver who has frequent and sufficient contact to provide accurate information about the patient's cognitive abilities and behaviors to complete the ALS-CBS.
• •8. Participants apt to comprehend and sign the ICF.
• •9. Participants of child-bearing potential must have a negative urine pregnancy test at screening and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• •1. Abstinence or agrees to use contraception if planning to become sexually active.
• •2. Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant
• •3. Double-barrier method
• •4. Intrauterine devices
• •5. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• •6. Vasectomy of partner at least 6 months prior to screening
• •10. Willing to maintain eating habits throughout the study.
• •11. Willing to refrain from consuming probiotic supplements and food containing added probiotics and/or prebiotics (e.g., yogurts with live, active cultures or supplements) from the moment of screening until the end of the study.
• •Healthy controls:
• •1. Aged 18 years old or greater.
• •2. Able to comprehend and willing to sign ICF.
• •3. Participants of child-bearing potential must have a negative urine pregnancy test at screening and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• •1. Abstinence or agrees to use contraception if planning to become sexually active.
• •2. Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant
• •3. Double-barrier method
• •4. Intrauterine devices
• •5. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• •6. Vasectomy of partner at least 6 months prior to screening
• •4. Willing to maintain eating habits throughout the study.
• •5. Willing to refrain from consuming probiotic supplements and food containing added probiotics and/or prebiotics (e.g., yogurts with live, active cultures or supplements) from the moment of screening until the end of the study
• •Informants/caregivers:
• •1. Aged 18 years old or greater.
• •2. Has frequent and sufficient contact to provide accurate information about the patient's cognitive abilities and behaviors to complete the ALS-CBS.
• •3. Able to comprehend and willing to sign ICF.