Probiotic Chocolate Study in Multiple Sclerosis

NCT06475183 | Completed

• 1 other identifier: AAAU8857
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Healthy Nutrition

Keywords

muliple sclerosis; probiotic

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  percent change in Th17 cells from baseline to week 6

  baseline (week 0) to week 6

• Change in serum microbial metabolites

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

  baseilne (week 0) to week 6

Secondary Outcomes (4)

• Change in Modified Fatigue Impact Scale-5 Impact Scale

  week 0, week 6

• Change in Patient-Determined Disability Scale (PDDS)

  week 0, week 6

• Change in Bowel Control Scale

  week 0, week 6

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

  week 0, week 6

Study Arms (1)

Probioitic consumption

EXPERIMENTAL

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

Interventions

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

Probioitic consumption

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls
• Age 18-45

You may not qualify if:

• diabetes
• tree nut allergy
• pregnancy

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rebecca Straus Farber, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)