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Completed

NCT Number: NCT06475183

Probiotic Chocolate Study in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Healthy Nutrition Immune System Diseases Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum

Dietary Supplement

Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum daily for 6 weeks

Primary outcomes

  1. peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells

    Time frame: baseline (week 0) to week 6

    percent change in Treg cells from baseline to week 6

  2. peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells

    Time frame: baseline (week 0) to week 6

    change in ratio of TH1 to Th2 cells from baseline to week 6

  3. peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells

    Time frame: baseline (week 0) to week 6

    percent change in Th17 cells from baseline to week 6

  4. Change in serum microbial metabolites

    Time frame: baseilne (week 0) to week 6

    percent change in short chain fatty acid levels from baseline to week 6

Secondary outcomes

  1. Change in Modified Fatigue Impact Scale-5 Impact Scale

    Time frame: week 0, week 6

    brief patient reported measure of fatigue, range of values is 0-20 with a higher score indicating worse outcome

  2. Change in Patient-Determined Disability Scale (PDDS)

    Time frame: week 0, week 6

    brief-patient reported meausre of disability in MS, range of values is 0-8 with higher score indicating worse outcome

  3. Change in Bowel Control Scale

    Time frame: 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

  4. Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale

    Time frame: week 0, week 6

    brief patient reported measure of disability in MS, range of scores is 0-32 with higher score indicating higher disability

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effects of Probiotics on Inflammatory Biomarkers in Persons With Multiple Sclerosis (MS) and in Family Members of Persons With MS

Acronym: ProChocolate

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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