An interventional study of Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in Multiple Sclerosis and Healthy Nutrition, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 92 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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Exclusion Criteria:
All pariticpants will consume Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in a quantity of 10 billium CFUs daily
Dietary Supplement: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum
Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum daily for 6 weeks
peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells
percent change in Treg cells from baseline to week 6
Time frame: baseline (week 0) to week 6
peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells
change in ratio of TH1 to Th2 cells from baseline to week 6
Time frame: baseline (week 0) to week 6
peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells
percent change in Th17 cells from baseline to week 6
Time frame: baseline (week 0) to week 6
Change in serum microbial metabolites
percent change in short chain fatty acid levels from baseline to week 6
Time frame: baseilne (week 0) to week 6
Change in Modified Fatigue Impact Scale-5 Impact Scale
brief patient reported measure of fatigue, range of values is 0-20 with a higher score indicating worse outcome
Time frame: week 0, week 6
Change in Patient-Determined Disability Scale (PDDS)
brief-patient reported meausre of disability in MS, range of values is 0-8 with higher score indicating worse outcome
Time frame: week 0, week 6
Change in Bowel Control Scale
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
Time frame: week 0, week 6
Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale
brief patient reported measure of disability in MS, range of scores is 0-32 with higher score indicating higher disability
Time frame: week 0, week 6
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Columbia University