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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether probiotic chocolate can influence the health of individuals with multiple sclerosis (MS), their close family members, and healthy individuals. Participants will consume a daily serving of Bouchard Belgian Dark Chocolate containing probiotics for six weeks. Researchers will compare blood samples taken before and after the chocolate period to identify changes in immune and gut health. Suitable candidates include those with MS, close family members of individuals with MS, or generally healthy individuals without diabetes or a nut allergy. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on diet and MS.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this probiotic chocolate is safe for consumption?

Research has shown that probiotics, like those in Bouchard Belgian Dark Chocolate Probiotic Napolitains, are generally safe to consume. These chocolates contain a type of beneficial bacteria called bifidobacterium longum. Other studies have found that most people can take probiotics without issues and with few side effects.

The chocolate is gluten-free, non-GMO, and vegan, accommodating various dietary needs. It contains less sugar than regular milk chocolate, which may benefit those mindful of their sugar intake. Although specific studies on the safety of this exact chocolate are lacking, probiotics are widely used and considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for multiple sclerosis, which often involve immune-modulating drugs, Probiotic Chocolate introduces a novel approach by utilizing Bouchard Belgian Dark Chocolate Probiotic Napolitains with bifidobacterium longum. This treatment is unique because it combines the indulgence of chocolate with the potential health benefits of probiotics, aiming to support gut health, which researchers believe might influence the immune system in a way that could benefit those with multiple sclerosis. The excitement around this treatment stems from its potential to offer a tasty, non-invasive alternative that could complement existing therapies and improve patient compliance due to its enjoyable form.

What evidence suggests that probiotic chocolate might be an effective treatment for multiple sclerosis?

Research suggests that probiotics, such as those in Bouchard Belgian Dark Chocolate Probiotic Napolitains, may offer health benefits. Studies have shown that probiotics can help maintain a healthy gut, which might also support the immune system. In individuals with multiple sclerosis (MS), the immune system mistakenly attacks the central nervous system, so boosting immune health could be beneficial. Dark chocolate is also known for reducing inflammation, which might help people with MS. Although specific data on using this combination for MS is limited, the individual ingredients show promise. Participants in this trial will consume Bouchard Belgian Dark Chocolate Probiotic Napolitains daily to explore these potential benefits. ^{3 6 7 8 9}

Who Is on the Research Team?

Rebecca Straus Farber, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. smartpatients.com smartpatients.com/trials/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 ...

2. ctv.veeva.com ctv.veeva.com/study/probiotic-chocolate-study-in-multiple-sclerosis

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 ...

3. bouchardchocolate.com bouchardchocolate.com/products/1-1-lb-belgian-dark-chocolate-probiotic-napolitains?srsltid=AfmBOorUagSxh6pWL_QTYaw-fasIujAKO3pYYiWX8w91gGugBrnskM_9

Probiotic Belgian Dark Chocolate Napolitains (72% Cacao) ... This 72% cacao dark chocolate is made in Belgium, has 1 billion live probiotics per piece, is gluten-free, non-GMO, vegan, and has 50% less sugar than milk ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9589144/

Dark chocolate: An overview of its biological activity ... Dark chocolate is considered a functional food due to its anti-diabetic, anti-inflammatory, and anti-microbial properties.

5. bouchardchocolate.com bouchardchocolate.com/products/bouchard-probiotic-dark-belgian-chocolate-72-cacao?srsltid=AfmBOor_r5REOJelzxsQ43tUkGLEDprIzUKHqRFt-StKx4P1zL5zokMW

Probiotic Belgian Dark Chocolate Napolitains (72% Cacao) ... We took our world-famous dark chocolate Napolitains and infused them with Probiotics. This is incredible dark Belgian chocolate and it's good for you.

6. bouchardchocolate.com bouchardchocolate.com/products/1-1-lb-belgian-dark-chocolate-probiotic-napolitains?srsltid=AfmBOoqWgEBzqQFaMq95NladfpNtN-BB8S_KzbonKMIz3L-oYq6978CO

Probiotic Belgian Dark Chocolate Napolitains (72% Cacao) ... This 72% cacao dark chocolate is made in Belgium, has 1 billion live probiotics per piece, is gluten-free, non-GMO, vegan, and has 50% less sugar than milk ...

7. bouchardchocolate.com bouchardchocolate.com/products/bouchard-probiotic-dark-belgian-chocolate-72-cacao?srsltid=AfmBOopoKULks1KzYOdd8245XlCMtOQhZY3TibaBnyHDB42JA7HnRO-t

Probiotic Belgian Dark Chocolate Napolitains (72% Cacao) ... Lots of other good things such as Gluten-Free, Non-GMO, Vegan friendly, Naturally antioxidant, 28 calories per piece and 50% less sugar than the average milk ...

8. amazon.com amazon.com/Bouchard-Probiotics-Belgian-Chocolate-Cacao/dp/B08XN8KVXN

Bouchard Probiotics Belgian Chocolate Dark 72% Cacao ... Dark Chocolate is a source of NATURAL FLAVONOIDS and other ANTIOXIDANTS, while PROBIOTICS help maintain cell health and improves the intestinal environment.

9. bouchardchocolate.com bouchardchocolate.com/collections/probiotic?srsltid=AfmBOooQArzwgbmgyK4GufLvkq4D6NKyvjJ4wzTqztHYcCiNxxqSyzsS

Probiotic Bouchard's probiotic dark chocolate has 1 billion live cultures per piece, 72% cacao, is gluten-free, non-GMO, vegan, and has 50% less sugar than milk ...