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

Korábbi kezelés

• Use of lipid-lowering drugs for less than 3 months before randomization.
• Use of edaravone with stable dosage for less than 2 months before randomization.
• Use of riluzole with stable dosage for less than 1 month before randomization.
• Immunodeficiency (immune-compromised and immune-suppressed participants, e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
• Use of probiotics other than the study medication in the month prior to randomization. Note: participants could be eligible to participate after a 4-week washout period.
• Use of any antibiotic drug in the month prior to randomization. Note: participants could be eligible to participate after a 4-week washout period.
• Use of lipid-lowering drugs for less than 3 months before randomization.
• Use of probiotics in the month prior to day 0 of the study (visit 2). Note: participants could be eligible to participate after a 4-week washout period. Although participants will not consume any study product, we aim to maintain environmental factors comparable to the ALS-FTDSD group.
• Use of any antibiotic drug in the month prior to day 0 of the study (visit 2). Note: participants could be eligible to participate after a 4-week washout period. Although participants will not consume any study product, we aim to maintain environmental factors comparable to the ALS-FTDSD group.

Más betegség

• Subjects with any of the following characteristics/conditions will not be included in the study:
• Significant medical condition or behavioral issues that could interfere with participation in the clinical trial in the principal investigator's opinion.
• Introduction of lipid-lowering drug unless it is due to the event of acute coronary syndrome or stroke as per Canadian guidelines.
• Milk and soy allergy, or severe lactose intolerance.
• Introduction of lipid-lowering drug unless it is due to the event of acute coronary syndrome or stroke as per Canadian guidelines.
• Milk and soy allergy, or severe lactose intolerance. Note: Although participants will not consume any study product, we aim to maintain environmental factors comparable to the ALS-FTDSD group. We aim to exclude allergies, so participants are maintained on standard diet.

Laborértékek

• Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding.
• Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding. Note: participants will not take the IP or placebo, but pregnancy is a major factor that could affect lipidomic profiling.

Egyéb

• ALS-FTDSD participants
• Use of respiratory support (non-invasive ventilation or mechanical respiratory support) at screening.
• Use of a feeding tube at randomization.
• Introduction of edaravone or riluzole during the clinical trial.
• Currently enrolled in another clinical trial.
  • Healthy controls:
• Currently enrolled in another clinical trial.

• Participants must meet all of the following inclusion criteria to be eligible for enrolment into the study:ALS-FTDSD participants
• Aged 18 years old or greater.
• Diagnosis of ALS by El Escorial Criteria revised (possible, probable, probable with lab support and definite).
• Onset of weakness or speech impairment no more than 24 months before randomization.
• ALSFRS-R equal or superior to 24/48 at screening, with no more than one subscore under 2/4.
• SVC greater than or equal to 60% predicted for sex, age and height at screening.
• 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.
• 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.
• Participants apt to comprehend and sign the ICF.
• Participants of child-bearing potential must have a negative serum 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:
  • Abstinence or agrees to use contraception if planning to become sexually active.
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant
  • Double-barrier method
  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening
• Willing to maintain eating habits throughout the study.
• 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:
• Aged 18 years old or greater.
• Able to comprehend and willing to sign ICF.
• Participants of child-bearing potential must have a negative serum 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:
  • Abstinence or agrees to use contraception if planning to become sexually active.
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant
  • Double-barrier method
  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening
• Willing to maintain eating habits throughout the study.
• 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.
  • Informant/caregiver
• Aged 18 years old or greater.
• Has frequent and sufficient contact to provide accurate information about the patient's cognitive abilities and behaviors to complete the ALS-CBS.
• Able to comprehend and willing to sign ICF