Probiotic Chocolate for Multiple Sclerosis

(ProChocolate Trial)

Overseen By Rifat Iqbal

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Diabetes, Tree nut allergy, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

92 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rebecca Straus Farber, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for people with multiple sclerosis, their first-degree relatives at higher genetic risk for MS, and healthy individuals. Participants will eat probiotic chocolate daily for 6 weeks and have blood tests before and after to check immune markers.

Inclusion Criteria

I have MS, am a close relative of someone with MS, or I am healthy.

Exclusion Criteria

I have a history of diabetes.

Pregnancy

History of tree nut allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ramp-up

Participants consume 2 probiotic chocolates per day to acclimate to the dosage

3 days

1 visit (in-person)

Treatment

Participants consume 5 probiotic chocolates per day for 6 weeks

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in immune markers and microbial metabolites

4 weeks

Treatment Details

Interventions

• Bouchard Belgian Dark Chocolate Probiotic Napolitains

Trial Overview The study is testing the effects of Bouchard Belgian Dark Chocolate Probiotic Napolitains containing bifidobacterium longum on immune function in MS patients, those at genetic risk, and healthy controls over a period of 6 weeks.

Participant Groups

Group I: Probioitic consumption Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+