Probiotic Chocolate Study in Multiple Sclerosis (ProChocolate)

March 28, 2025 updated by: Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probioitic consumption
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseilne (week 0) to week 6
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
baseline (week 0) to week 6
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
baseline (week 0) to week 6
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
baseline (week 0) to week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 0, week 6
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
week 0, week 6
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
week 0, week 6
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
week 0, week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Rebecca Straus Farber, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 9, 2024

Study Completion (Actual)

December 9, 2024

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU8857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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