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

NCT ID: NCT04574024

Last Updated: 2024-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2024-07-15

Brief Summary

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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.

Detailed Description

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Our collaborator, Dr. Liping Zhao, developed a high-fiber supplement (HFS), NBT-NM108. His recent study has suggested an association between intake of NBT-NM108 and increased abundance of short-chain fatty acid (SCFA)-producing gut bacteria. Recent studies have suggested that Relapsing-Remitting Multiple Sclerosis (RRMS) is associated with gut dysbiosis, alteration of gut bacteria, and decreased production of SCFAs. Therefore, we have investigated the effect of NBT-NM108 on RRMS-associated gut dysbiosis and the cytokines produced by immune cells. Seven patients were enrolled, and their stool samples were collected before the treatment with NBT-NM108 (Baseline). Three patients from the enrolled patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks. Two patients further consumed NBT-NM108 for four more weeks (a total of 12 weeks). Stool and blood samples were collected at 3 time points (baseline, 8 weeks post-NBT-NM108, and 12 weeks post-NBT-NM108). We have investigated the effect of NBT-NM108 on gut microbiota and immune parameters involved in MS.

Conditions

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Multiple Sclerosis

Keywords

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High-fiber supplement

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

High-fiber supplement-treatment and non-treatment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MS study cohort

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

Group Type OTHER

NBT-NM108

Intervention Type DRUG

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

Interventions

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NBT-NM108

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suhayl Dhib-Jalbut, MD

OTHER

Sponsor Role lead

Responsible Party

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Suhayl Dhib-Jalbut, MD

Professor of Neurology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Suhayl Dhib-Jalbut, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers-RWJMS

Locations

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Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro2019001677

Identifier Type: -

Identifier Source: org_study_id