What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as interferon beta-1a, interferon beta-1b, and fingolimod. Interferon beta-1a and beta-1b can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Fingolimod is associated with headache, elevated liver enzymes, diarrhea, cough, flu, sinusitis, back pain, and more serious risks like bradyarrhythmia, macular edema, and increased susceptibility to infections. While high-fiber supplements are being studied for their potential to promote gut health and immune regulation in MS, their side effects are generally mild and include gastrointestinal discomfort.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) primarily focus on modulating the immune system to reduce disease activity and progression. These include interferon beta-1a and beta-1b, which are injectable medications that help reduce inflammation and the frequency of relapses. Another approved treatment is dimethyl fumarate (BG-12), an oral medication that has anti-inflammatory and neuroprotective effects. Glatiramer acetate is another injectable drug that modifies immune processes. While these treatments do not specifically target gut bacteria, they share the common goal of influencing immune regulation to manage MS.

What other types of research exist?

Promising alternatives to high-fiber supplements for MS patients include prebiotics such as short-chain fructooligosaccharides (scFOS) and inulin, probiotics like Lactobacillus and Bifidobacterium strains, and synbiotics that combine both prebiotics and probiotics.

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Other

High-Fiber Supplement for Multiple Sclerosis

Phase 1 & 2

Waitlist Available

Research Sponsored by Suhayl Dhib-Jalbut, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with first demyelinating event who meet the McDonald criteria for definite MS or established relapsing remitting MS patients.

Be between 18 and 65 years old

Must not have

Having received prior chemotherapy.

Cognitively impaired.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of first documented progression, assessed up to 36 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include gastrointestinal discomfort such as bloating and gas due to increased fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone chemotherapy before.

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I have difficulty with thinking or memory.

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I have or had cancer before.

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I have taken Dimethylfumarate (DMF).

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I have taken antibiotics in the last 6 months.

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My condition is progressive multiple sclerosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of first documented progression, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of first documented progression, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of first documented progression, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of high-fiber supplement (HFS) on (1) composition of gut microbiota and (2)production of short-chain fatty acids (SCFAs) and Foxp3 regulatory T cells (Tregs).

Examine fecal Lcn-2 levels before/after MS relapse

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort A: Treatment with NBT-NM108�Experimental Treatment1 Intervention

Patients will receive NBT-NM108 at 60 g/day for 8 weeks.

Group II: Cohort B: Non-treatmentPlacebo Group1 Intervention

Patients will not receive NBT-NM108.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) often aim to modulate the immune system and reduce inflammation. High-fiber supplements promote the growth of short-chain fatty acid-producing gut bacteria, which can influence the development of regulatory immune cells and potentially correct gut dysbiosis, a condition linked to MS. This is important for MS patients as it offers a non-invasive way to potentially manage disease activity. Other treatments, such as interferon beta-1a, work by reducing the frequency of relapses and slowing disease progression through immune modulation. Probiotics have also shown promise in improving balance and immune function. These treatments matter for MS patients as they provide various strategies to manage symptoms and improve quality of life by targeting different aspects of the disease's pathology.

Immunomodulatory and anti-inflammatory effects of probiotics in multiple sclerosis: a systematic review.Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.