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Compensation: Varies

Number of Visits: 4

Duration: 8-12 weeks

7 Participants Needed

High-Fiber Supplement for Multiple Sclerosis

Overseen ByKouichi 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 GroupAll trial participants will receive the active study treatment (no placebo)

Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing a high-fiber supplement on patients with Relapsing Remitting Multiple Sclerosis (RRMS). The supplement aims to grow healthy gut bacteria, which may help regulate the immune system and reduce MS symptoms.

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.

What data supports the effectiveness of the treatment NBT-NM108, NBT-NM108, Guild:Plus for multiple sclerosis?

Research on high-dose biotin, a component similar to the treatment, shows it can help reduce disability progression in people with progressive multiple sclerosis. Additionally, broad-spectrum dietary supplements have been found to improve quality of life and symptom severity in MS patients.¹ ² ³ ⁴ ⁵

How is the treatment NBT-NM108 different from other multiple sclerosis treatments?

NBT-NM108 is a high-fiber supplement, which is unique compared to traditional multiple sclerosis treatments that often involve drugs. This approach may offer a novel way to manage the condition by potentially influencing the gut microbiome, which plays a role in autoimmunity.¹ ² ³ ⁴ ⁶

Research Team

Suhayl Dhib-Jalbut, MD

Principal Investigator

Rutgers-RWJMS

Eligibility Criteria

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.

See 8 more

Timeline

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

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MS study cohortExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Suhayl Dhib-Jalbut, MD

Lead Sponsor

Trials

Recruited

Findings from Research

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]

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 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]