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

Completed · Phase 1/Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT04574024

Run by

Suhayl Dhib-Jalbut, MD

People needed

7

Starts

2022-03-21

Expected to finish

2024-07-15

Last updated by the study team

2024-12-17

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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