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HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)

CompletedPhase 1, Phase 2

Sponsor: Suhayl Dhib-Jalbut, MD

Conditions: Multiple Sclerosis

Interventions: NBT-NM108

Countries: United States

Multiple sclerosis (MS) is an autoimmune disease directed against the Central Nervous System (CNS). Recent studies have indicated that changes in the gut microbiota are associated with disease initiation and progression. The reduction of bacterial taxa involved in producing health-promoting metabolites, such as short-chain fatty acids (SCFAs), has been reported in MS patients. SCFAs play an important role in the suppression of inflammation. The levels of SCFAs in the blood of MS patients are significantly reduced when compared to those of healthy controls. Since the intake of dietary fiber increases the growth of SCFA-producing bacteria, we investigated the effect of a high-fiber supplement (HFS) on gut bacteria and immunological parameters in MS patients.

Eligibility overview

Sex: ALL

Age: 21 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.

Exclusion Criteria:

1. Primary or secondary progressive MS.
2. Patients with autoimmune comorbidities.
3. Having received prior chemotherapy.
4. Having received Dimethylfumarate (DMF).
5. Pregnant women.
6. Cognitively impaired.
7. Antibiotic use within last 6 months.
8. Probiotic use within 2 months.
9. Self-reported allergy or intolerance to any ingredients in the fiber supplement.
10. Self-reported or diagnosed gastrointestinal symptoms, disorders or adenomas.
11. Active or history of malignant tumors.

Locations (1)

New Brunswick, New Jersey, United States