Clinical trial NCT06475183: Probiotic Chocolate Study in Multiple Sclerosis
Official title: Effects of Probiotics on Inflammatory Biomarkers in Persons With Multiple Sclerosis (MS) and in Family Members of Persons With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Healthy Nutrition
Keywords: muliple sclerosis
probiotic
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells
timeFrame: baseline (week 0) to week 6
measure: peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells
timeFrame: baseline (week 0) to week 6
measure: peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells
timeFrame: baseline (week 0) to week 6
measure: Change in serum microbial metabolites
timeFrame: baseilne (week 0) to week 6
Secondary outcomes:
measure: Change in Modified Fatigue Impact Scale-5 Impact Scale
timeFrame: week 0, week 6
measure: Change in Patient-Determined Disability Scale (PDDS)
timeFrame: week 0, week 6
measure: Change in Bowel Control Scale
timeFrame: week 0, week 6
measure: Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale
timeFrame: week 0, week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Straus Farber, MD
role: PRINCIPAL_INVESTIGATOR
References: