Probiotic Chocolate Study in Multiple Sclerosis
- Conditions
- Multiple SclerosisHealthy Nutrition
- Interventions
- Dietary Supplement: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum
- Registration Number
- NCT06475183
- Lead Sponsor
- Columbia University
- Brief Summary
The goal of this study is to assess the effects of probiotics on persons with multiple sclerosis (MS), persons at higher genetic risk for MS (first degree family members of persons with MS), and healthy controls. Participants will be asked to consume probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum per day) for 6 weeks. Participants will undergo blood draws before and after the 6 weeks of probiotic containing chocolate and microbial metabolites and immune markers will be compared before and after the probiotics, as well as between groups.
- Detailed Description
The goal of this study is to assess the effects of probiotics in persons with MS (PwMS), persons at high genetic risk for MS (first degree family members of PwMS), and healthy controls. PwMS. Subjects undergo blood draws and will complete surveys on neurological symptoms (as relevant). Subjects are given a supply of individually wrapped probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains) along with instructions on proper storage, dosage, and a diary to complete regarding supplement adherence. After a "ramp up" period of 3 days during which participants will consume take 2 chocolates per day, participants consume 5 chocolates per day (10 billion CFUs of bifidobacterium longum per day) for 6 weeks. After 6 weeks participants return the adherence diaries and answer questions about probiotic tolerance. They also repeat similar surveys and again undergo blood draws. Serum levels of microbial metabolites and peripheral blood immune profiles are assessed before and after supplementation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls
- Age 18-45
- diabetes
- tree nut allergy
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Probioitic consumption Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum All pariticpants will consume Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in a quantity of 10 billium CFUs daily
- Primary Outcome Measures
Name Time Method peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells baseline (week 0) to week 6 percent change in Th17 cells from baseline to week 6
peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells baseline (week 0) to week 6 percent change in Treg cells from baseline to week 6
Change in serum microbial metabolites baseilne (week 0) to week 6 percent change in short chain fatty acid levels from baseline to week 6
peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells baseline (week 0) to week 6 change in ratio of TH1 to Th2 cells from baseline to week 6
- Secondary Outcome Measures
Name Time Method Change in Patient-Determined Disability Scale (PDDS) week 0, week 6 brief-patient reported meausre of disability in MS, range of values is 0-8 with higher score indicating worse outcome
Change in Bowel Control Scale week 0, week 6 brief patient reported measure of bowel control and impact of bowel problems on everyday life, range of scores is 0-16 with higher score indicating worse outcome
Change in Modified Fatigue Impact Scale-5 Impact Scale week 0, week 6 brief patient reported measure of fatigue, range of values is 0-20 with a higher score indicating worse outcome
Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale week 0, week 6 brief patient reported measure of disability in MS, range of scores is 0-32 with higher score indicating higher disability
Trial Locations
- Locations (1)
Columbia University Irving Medical Center
🇺🇸New York, New York, United States