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

Официальное название

Effects of Probiotics on Lipidomic Profile and Disease Evolution in ALS-FTDSD Patients: A Randomized Multicenter, Double-blind, Phase II, Placebo-controlled, Parallel Trial.

Обзор

The aim of this study is to assess the impact of a probiotic formulation on participants with ALS-FTDSD. It is hypothesized that participants given the probiotics will have different lipid profiles compared to participants receiving the placebo at different time points.

Подробное описание

Individuals with ALS-FTDSD, their caregivers and healthy individuals can participate in this randomized, double-blind, parallel, placebo-controlled study. Participants will be enrolled for a period of 32 weeks, with an intervention period of 24 weeks. For ALS-FTDSD participants, there will be 9 visits during the intervention (5 in-person and 4 phone calls) and 1 follow-up call post-intervention. For healthy participants, there will be 4 in-person visits. For all participants, in-person visits will involve filling out questionnaires, giving blood samples, and returning stool samples.

Вмешательства

• Пищевая добавка Probiotic
  Participants will be taking 1 sachet a day.
• Пищевая добавка Placebo
  Participants will be taking 1 sachet a day.

Первичные конечные точки

• Change in lipids and polar metabolites composition in the plasma of participant [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• Change in ALS Functional Rating Scale Revised (ALSFRS-R) score [Срок оценки: 24 weeks]
• Change in ALS-CBS score [Срок оценки: 24 weeks]
• Change in neurofilament light chain concentration [Срок оценки: 24 weeks]
• Change in ALSAQ-5 scores [Срок оценки: 24 weeks]
• Change in fecal microbiota in ALS-FTDSD patients [Срок оценки: 24 weeks]
• Lipidomic profiles of healthy participants [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

Subjects with any of the following characteristics/conditions will not be included in the study:

ALS-FTDSD participants

• Use of respiratory support (non-invasive ventilation or mechanical respiratory support) at screening.
• Significant medical condition or behavioral issues that could interfere with participation in the clinical trial in the principal investigator's opinion.
• Use of a feeding tube at randomization.
• Use of lipid-lowering drugs for less than 3 months before randomization.
• Introduction of lipid-lowering drug unless it is due to the event of acute coronary syndrome or stroke as per Canadian guidelines.
• 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.
• Introduction of edaravone or riluzole during the clinical trial.
• Immunodeficiency (immune-compromised and immune-suppressed participants, e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
• Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding.
• 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.
• Milk and soy allergy, or severe lactose intolerance.
• Currently enrolled in another clinical trial.

Healthy controls:

• Use of lipid-lowering drugs for less than 3 months before randomization.
• Introduction of lipid-lowering drug unless it is due to the event of acute coronary syndrome or stroke as per Canadian guidelines.
• 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.
• 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.
• 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.
• Currently enrolled in another clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 3 центра

• Stan Cassidy Centre for Rehabilitation — Fredericton
• Centre Hospitalier de l'Université de Montréal — Montreal
• University of Saskatchewan, Clinical Trials Support Unit — Saskatoon

Идентификаторы

NCT: NCT06051123 · 2024-11453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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