Probiotic Chocolate Study in Multiple Sclerosis (ProChocolate)

Columbia University

Status: Completed

Conditions: Multiple Sclerosis; Healthy Nutrition

Treatments: Dietary Supplement: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum

Study type: Interventional

Funder types: Other

Identifiers

NCT06475183

AAAU8857

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Probioitic consumption

Experimental group

Description:

All pariticpants will consume Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in a quantity of 10 billium CFUs daily

Treatment:

Dietary Supplement: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum