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

NCT04574024 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-12-17

Study results available
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Summary

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.

Conditions

Interventions

DRUG

NBT-NM108

MS Patients received NBT-NM108 at 60 g/day.

Sponsors & Collaborators

  • Suhayl Dhib-Jalbut, MD

    lead OTHER

Principal Investigators

  • Suhayl Dhib-Jalbut, MD · Rutgers-RWJMS

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2024-06-30
Completion
2024-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04574024 on ClinicalTrials.gov