High-Fiber Supplement for Multiple Sclerosis

Overseen By Kouichi Ito, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Suhayl Dhib-Jalbut, MD

Must not be taking: Antibiotics, Probiotics, Chemotherapy, DMF

Disqualifiers: Progressive MS, Autoimmune, Pregnant, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a high-fiber supplement called NBT-NM108 to determine its potential benefits for people with multiple sclerosis (MS). MS occurs when the immune system attacks the brain and spinal cord. The study aims to assess whether boosting certain gut bacteria with fiber can reduce inflammation. Participants will take the supplement for either 8 or 12 weeks. Individuals who have experienced their first MS attack and meet specific criteria for relapsing-remitting MS may qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have used antibiotics in the last 6 months or probiotics in the last 2 months, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found that NBT-NM108, a high-fiber supplement, increased the amount of good bacteria in the gut. These bacteria produce substances that help reduce inflammation.

Research has shown that NBT-NM108 is generally well-tolerated. In one instance, it significantly eased digestive symptoms without causing harmful effects. While this suggests the supplement is safe, more studies are needed to fully understand its safety for people with multiple sclerosis.

Since the trial is in its early stages, it mainly focuses on safety. The supplement looks promising, but researchers are still gathering information on its safety for a larger group of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MS?

Unlike standard treatments for multiple sclerosis, which often include immunomodulators or steroids, NBT-NM108 is a high-fiber supplement that takes a dietary approach to managing the condition. Researchers are excited about NBT-NM108 because it targets gut health, potentially impacting inflammation and immune response, which are central to multiple sclerosis. This innovative mechanism offers a non-pharmaceutical option that could complement existing therapies and provide additional benefits without the side effects commonly associated with traditional medications.

What evidence suggests that this high-fiber supplement might be an effective treatment for multiple sclerosis?

Studies have shown that changes in gut bacteria are linked to multiple sclerosis (MS). People with MS often have fewer bacteria that produce short-chain fatty acids (SCFAs), which help reduce inflammation. Research suggests that increasing dietary fiber can boost these beneficial bacteria. In this trial, participants will receive a high-fiber supplement, NBT-NM108. Early findings indicate that this supplement can raise SCFA levels in people with MS. This increase might help reduce inflammation in the central nervous system, potentially easing MS symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Suhayl Dhib-Jalbut, MD

Principal Investigator

Rutgers-RWJMS

Are You a Good Fit for This Trial?

This trial is for Caucasian individuals with a first demyelinating event meeting McDonald criteria for MS or established relapsing-remitting MS, treated with Glatiramer acetate or Fingolimod. Excluded are pregnant women, those who've had chemotherapy or taken DMF, have progressive MS, allergies to the supplement's ingredients, other autoimmune diseases, cognitive impairments, recent antibiotic or probiotic use.

Inclusion Criteria

I have been treated with Glatiramer acetate or Fingolimod for my MS for at least 6 months.

The study is only open to people of Caucasian descent because research shows that they are more likely to develop MS. Additionally, the Western diet, which is common among Caucasians, may increase the risk of developing MS.

I have been diagnosed with multiple sclerosis following my first demyelinating event.

Exclusion Criteria

I have undergone chemotherapy before.

I have taken probiotics in the last 2 months.

I have difficulty with thinking or memory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Stool samples collected from 7 MS patients before treatment

Baseline

1 visit (in-person)

Treatment

3 patients consumed NBT-NM108 for 8 weeks, 2 patients continued for 12 weeks

8-12 weeks

3 visits (in-person) at baseline, 8 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NBT-NM108

Trial Overview The study tests a high-fiber supplement (NBT-NM108) at 60 g/day versus no supplement in managing Multiple Sclerosis by promoting healthy gut bacteria growth and regulatory immune cells. It also explores fecal Lcn-2 as a non-invasive biomarker for gut dysbiosis-mediated CNS autoimmunity in MS.

How Is the Trial Designed?

Group I: MS study cohort Experimental Treatment 1 Intervention

Baseline: 7 MS patients enrolled for the study. No treatment or before treatment. NBT-NM108-Treatment for 8 weeks: 3 out of 7 MS patients consumed the NBT-NM108 for 8 weeks. NBT-NM108-Treatment for 12 weeks: 2 MS patients further consumed the NBT-NM108 for four more weeks. Patients consumed dietary fiber three times a day at 60 g/day

NBT-NM108 is already approved in United States for the following indications:

Approved in United States as NBT-NM108 for:

• COVID-19 in patients with type 2 diabetes and prediabetes

Who Is Running the Clinical Trial?

Suhayl Dhib-Jalbut, MD

Lead Sponsor

Trials

1

Recruited

7+

Published Research Related to This Trial

In a study of 48 patients with progressive multiple sclerosis treated with high-dose biotin (MD1003) for one year, 27% showed significant clinical improvement as measured by the Expanded Disability Status Scale and other functional tests.

The treatment was also associated with increases in brain and cervical spinal cord volume in some patients, suggesting that MD1003 may have neuroprotective effects, particularly in less disabled individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of treatment response in patients with progressive multiple sclerosis treated with high-dose pharmaceutical-grade biotin (MD1003). Collongues, N., Kuhle, J., Tsagkas, C., et al.[2022]

In a study of 178 patients with progressive multiple sclerosis, high-dose biotin supplementation did not show a significant improvement in disability progression after 12 months, with only 3.8% of patients experiencing an improved Expanded Disability Status Scale (EDSS) score.

While 47.4% of patients reported stability in their condition, a notable 25% experienced worsening symptoms, and 14% reported adverse events, indicating that high-dose biotin may not be an effective treatment in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose biotin in progressive multiple sclerosis: A prospective study of 178 patients in routine clinical practice. Couloume, L., Barbin, L., Leray, E., et al.[2022]

In a study involving 43 patients with progressive multiple sclerosis, high dose biotin (300 mg/day) was found to be safe and well tolerated, with no evidence of toxicity or new brain lesions after one year.

Despite its safety, high dose biotin did not improve neurological function, and over one-third of patients experienced worsening symptoms, suggesting that while biotin is safe, it may not provide the expected benefits for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose biotin as treatment for progressive multiple sclerosis. Birnbaum, G., Stulc, J.[2018]

Citations

1. researchgate.net researchgate.net/publication/374376035_Interaction_of_the_Gut_Microbiome_and_Immunity_in_Multiple_Sclerosis_Impact_of_Diet_and_Immune_Therapy

Interaction of the Gut Microbiome and Immunity in Multiple ... Growing evidence suggests that gut immunity is critically involved in gut–brain communication during health and diseases, including multiple ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04574024?term=AREA%5BConditionSearch%5D(multiple%20sclerosis)%20AND%20AREA%5BBasicSearch%5D(multiple%20sclerosis)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=4&tab=results

HFS (High-Fiber Supplement) in MS (Multiple Sclerosis) The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04574024

HFS (High-Fiber Supplement) in MS (Multiple Sclerosis) See Delay Results Type in the Results Data Element definitions for more information about this certification. ... MS Patients received NBT-NM108 at 60 g/day.

4. withpower.com withpower.com/trial/phase-2-multiple-sclerosis-2021-f1fd7

High-Fiber Supplement for Multiple Sclerosis What data supports the effectiveness of the treatment NBT-NM108, NBT-NM108, Guild:Plus for multiple sclerosis? Research on high-dose biotin, a component ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10572709/

Interaction of the Gut Microbiome and Immunity in Multiple ... This review will address the role of gut immunity and its modulation by diet and DMTs via gut microbiota during MS pathophysiology.

6. research.rutgers.edu research.rutgers.edu/news/new-formula-developed-rutgers-researcher-proves-promising-alleviating-gastrointestinal

New Formula Developed by Rutgers Researcher Proves ... The results, now published, establish that the high intake of the NBT-NM108 formula significantly alleviated her severe GI symptoms and other ...