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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NBT-NM108 (60 g/day)
NBT-NM108 (0 g/day)
Sponsored by
Suhayl Dhib-Jalbut, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring High-fiber supplement

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with first demyelinating event who meet the McDonald criteria for definite MS or established relapsing remitting MS patients.
  2. We will recruit Caucasian due to reports suggesting higher incidence of MS in Caucasian. Also, western diet which is common among Caucasian can promote MS.
  3. MS patients treated with either Glatiramer acetate or Fingolimod for at least 6 months prior to enrollment.

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

Sites / Locations

  • Robert Wood Johnson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cohort A: Treatment with NBT-NM108�

Cohort B: Non-treatment

Arm Description

Patients will receive NBT-NM108 at 60 g/day for 8 weeks.

Patients will not receive NBT-NM108.

Outcomes

Primary Outcome Measures

Effect of high-fiber supplement (HFS) on (1) composition of gut microbiota and (2)production of short-chain fatty acids (SCFAs) and Foxp3 regulatory T cells (Tregs).
(1) The fecal sample will be collected from MS patients with/without high-fiber supplement (HFS) and composition of gut microbiota will be examined. (2) The blood cells will be isolated from MS patients with/without HFS-treatment and production of SCFAs such as acetate, propionate, and butyrate, and development of Foxp3 Tregs will be examined.
Examine fecal Lcn-2 levels before/after MS relapse
Fecal Lcn-2 levels will be examined in MS patients with remission and relapse

Secondary Outcome Measures

Full Information

First Posted
September 21, 2020
Last Updated
November 1, 2021
Sponsor
Suhayl Dhib-Jalbut, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04574024
Brief Title
HFP (High-Fiber Supplement) in MS (Multiple Sclerosis)
Official Title
Effect of High-fiber Supplement in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suhayl Dhib-Jalbut, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It has been suggested that dysbiosis of gut commensal bacteria increases the risk of autoimmune diseases including MS. However, there is no viable intervention available to correct dysbiosis. Since high-fiber supplement can promote the growth of healthy bacteria in the gut, the investigators propose to examine the effect of specially designed high-fiber supplement on the growth of short-chain fatty acid-producing gut bacteria and development of regulatory immune cells. Although dysbiosis is an alteration of microbial composition, enteric bacteria involved in gut dysbiosis of MS are different in ethnic groups due to difference in genetics, diet, and environmental exposures. Therefore, it is important to determine the intestinal bacterial composition involved in the MS dysbiosis in each ethnicity and geographical location. Additionally, it is necessary to find a non-invasive biomarker for gut dysbiosis-mediated CNS autoimmunity in MS. Since the investigators found that fecal Lipocalin 2 (Lcn-2) is a biomarker of gut dysbiosis-mediated CNS autoimmunity in MS animal models, the investigators will examine the association of fecal Lcn-2 levels with disease activation in MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
High-fiber supplement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
High-fiber supplement-treatment and non-treatment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Treatment with NBT-NM108�
Arm Type
Experimental
Arm Description
Patients will receive NBT-NM108 at 60 g/day for 8 weeks.
Arm Title
Cohort B: Non-treatment
Arm Type
Placebo Comparator
Arm Description
Patients will not receive NBT-NM108.
Intervention Type
Drug
Intervention Name(s)
NBT-NM108 (60 g/day)
Intervention Description
Patients will receive NBT-NM108 at 60 g/day.
Intervention Type
Other
Intervention Name(s)
NBT-NM108 (0 g/day)
Intervention Description
Patients will receive NBT-NM108 at 0 g/day.
Primary Outcome Measure Information:
Title
Effect of high-fiber supplement (HFS) on (1) composition of gut microbiota and (2)production of short-chain fatty acids (SCFAs) and Foxp3 regulatory T cells (Tregs).
Description
(1) The fecal sample will be collected from MS patients with/without high-fiber supplement (HFS) and composition of gut microbiota will be examined. (2) The blood cells will be isolated from MS patients with/without HFS-treatment and production of SCFAs such as acetate, propionate, and butyrate, and development of Foxp3 Tregs will be examined.
Time Frame
Change from baseline to day183
Title
Examine fecal Lcn-2 levels before/after MS relapse
Description
Fecal Lcn-2 levels will be examined in MS patients with remission and relapse
Time Frame
From date of randomization until the date of first documented progression, assessed up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with first demyelinating event who meet the McDonald criteria for definite MS or established relapsing remitting MS patients. We will recruit Caucasian due to reports suggesting higher incidence of MS in Caucasian. Also, western diet which is common among Caucasian can promote MS. MS patients treated with either Glatiramer acetate or Fingolimod for at least 6 months prior to enrollment. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suhayl Dhib-Jalbut, MD
Organizational Affiliation
Rutgers-RWJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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