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

Effect of High-fiber Supplement in Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: NBT-NM108

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Drug: NBT-NM108; MS Patients received NBT-NM108 at 60 g/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients	TNF-alpha is involved in MS pathology, therefore, we examined the serum level of TNF-alpha by Luminex multiplex assay.	Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.	The abundance of the bacteria genus "Anaerostipes" is often found to be decreased in MS patients compared to healthy individuals, indicating a potential link in MS disease progression. Therefore, we examined the abundance by 16s rRNA sequencing of V3-V4 region.	Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients	Recently, we found that fecal Lcn-2 level is a sensitive biological indicator for gut dysbiosis in MS. Fecal Lcn-2 levels are increased upon development of gut dysbiosis. Therefore, we measured fecal Lcn-2 levels at baseline, 8 and 12 weeks of HFS treatment.	Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.

Collaborators and Investigators

• Sponsor: Suhayl Dhib-Jalbut, MD
• Investigators: Principal Investigator: Suhayl Dhib-Jalbut, MD, Rutgers-Rwjms

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: High-fiber supplement
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: Pro2019001677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No