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

NCT04574024 | Completed Phase 1 Results FDA Drug

• 1 other identifier: Pro2019001677
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

High-fiber supplement

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

MS study cohort

OTHER

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

Interventions

NBT-NM108 DRUG

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

MS study cohort

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Suhayl Dhib-Jalbut, MD: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

We were unable to enroll proposed number of MS patients due to the COVID pandemic.

Results Point of Contact

• Title: Suhayl Dhib-Jalbut
• Organization: Rutgers, The State University of New Jersey

jalbutsu@rwjms.rutgers.edu

732-235-7335

Study Officials

• Suhayl Dhib-Jalbut, MD

  Rutgers-RWJMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: High-fiber supplement-treatment and non-treatment

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 5, 2020
• Study Start: March 21, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)