Multiple SclerosisProChocolateNCT06475183
Probiotic Chocolate Study in Multiple Sclerosis
A study testing Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in people with Multiple Sclerosis and Healthy Nutrition, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy Nutrition
- What is being tested?
- Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls
- Age 18-45
Who cannot join
- diabetes
- tree nut allergy
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Healthy Nutrition
- Being tested
- Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum
- Keywords
- muliple sclerosis, probiotic
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longumDietary supplement
Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probioitic consumption | Experimental | All pariticpants will consume Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in a quantity of 10 billium CFUs daily Receives: Dietary Supplement: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells
percent change in Treg cells from baseline to week 6
Measured: 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
Measured: 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
Measured: baseline (week 0) to week 6
Change in serum microbial metabolites
percent change in short chain fatty acid levels from baseline to week 6
Measured: baseilne (week 0) to week 6
Secondary outcomes (4)
Change in Modified Fatigue Impact Scale-5 Impact Scale
brief patient reported measure of fatigue, range of values is 0-20 with a higher score indicating worse outcome
Measured: week 0, week 6
Change in Patient-Determined Disability Scale (PDDS)
brief-patient reported meausre of disability in MS, range of values is 0-8 with higher score indicating worse outcome
Measured: week 0, week 6
Change in Bowel Control Scale
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
Measured: week 0, week 6
Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale
brief patient reported measure of disability in MS, range of scores is 0-32 with higher score indicating higher disability
Measured: week 0, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jun 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Straus Farber, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475183
- Sponsor's protocol ID
- AAAU8857
- Acronym
- ProChocolate
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Inflammatory Biomarkers in Persons With Multiple Sclerosis (MS) and in Family Members of Persons With MS
- ClinicalTrials.gov ID
- NCT06475183
- Acronym / sponsor ID
- ProChocolate / AAAU8857
- Conditions
- Multiple Sclerosis, Healthy Nutrition
- Keywords
- muliple sclerosis, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probioitic consumption | Experimental | Dietary Supplement: Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longumAll pariticpants will consume Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in a quantity of 10 billium CFUs daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls
- Age 18-45
Key exclusion criteria (3 listed)
- diabetes
- tree nut allergy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longumBouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum daily for 6 weeks | Dietary supplement | Probioitic consumption |
Primary outcome
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
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
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
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
4 secondary outcomes
Change in Modified Fatigue Impact Scale-5 Impact Scale
Time frame: week 0, week 6
Change in Patient-Determined Disability Scale (PDDS)
Time frame: week 0, week 6
Change in Bowel Control Scale
Time frame: week 0, week 6
Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale
Time frame: week 0, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Straus Farber, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum in people with Multiple Sclerosis and Healthy Nutrition, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells (time frame: baseline (week 0) to week 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.