Healthy Nutrition, Multiple Sclerosis
Conditions
Keywords
muliple sclerosis, probiotic
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.
Interventions
DIETARY_SUPPLEMENTBouchard 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
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls * Age 18-45
Exclusion criteria
* diabetes * tree nut allergy * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Regulatory T (Treg) cells | baseline (week 0) to week 6 | percent change in Treg cells 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
United States
Outcome results
None listed