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High-Fiber Supplement for Multiple Sclerosis
Phase 1 & 2
Waitlist Available
Research Sponsored by Suhayl Dhib-Jalbut, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with first demyelinating event who meet the McDonald criteria for definite MS or established relapsing remitting MS patients.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of first documented progression, assessed up to 36 months
Awards & highlights
Study Summary
This trial will examine the effect of a specially designed high-fiber supplement on the growth of short-chain fatty acid-producing gut bacteria and development of regulatory immune cells in people with MS.
Who is the study for?
This trial is for Caucasian individuals with a first demyelinating event meeting McDonald criteria for MS or established relapsing-remitting MS, treated with Glatiramer acetate or Fingolimod. Excluded are pregnant women, those who've had chemotherapy or taken DMF, have progressive MS, allergies to the supplement's ingredients, other autoimmune diseases, cognitive impairments, recent antibiotic or probiotic use.Check my eligibility
What is being tested?
The study tests a high-fiber supplement (NBT-NM108) at 60 g/day versus no supplement in managing Multiple Sclerosis by promoting healthy gut bacteria growth and regulatory immune cells. It also explores fecal Lcn-2 as a non-invasive biomarker for gut dysbiosis-mediated CNS autoimmunity in MS.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include gastrointestinal discomfort such as bloating and gas due to increased fiber intake.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple sclerosis following my first demyelinating event.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first documented progression, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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).
Examine fecal Lcn-2 levels before/after MS relapse
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort A: Treatment with NBT-NM108�Experimental Treatment1 Intervention
Patients will receive NBT-NM108 at 60 g/day for 8 weeks.
Group II: Cohort B: Non-treatmentPlacebo Group1 Intervention
Patients will not receive NBT-NM108.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Suhayl Dhib-Jalbut, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone chemotherapy before.I have taken probiotics in the last 2 months.I have been treated with Glatiramer acetate or Fingolimod for my MS for at least 6 months.I have difficulty with thinking or memory.I have had stomach or bowel problems or growths.I have or had cancer before.The study is only open to people of Caucasian descent because research shows that they are more likely to develop MS. Additionally, the Western diet, which is common among Caucasians, may increase the risk of developing MS.I have taken Dimethylfumarate (DMF).I have taken antibiotics in the last 6 months.My condition is progressive multiple sclerosis.You are pregnant.I have been diagnosed with multiple sclerosis following my first demyelinating event.You have reported an allergy or intolerance to any of the ingredients in the fiber supplement.You have an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Treatment with NBT-NM108�
- Group 2: Cohort B: Non-treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available to participate in the research?
"According to clinicaltrials.gov, the enrollment period of this trial has now closed; however it was initially posted on November 16th 2021 and last updated on the 1st of November. There are currently 549 other medical studies actively looking for new applicants."
Answered by AI
What are the qualifications for participation in this experiment?
"Prospective participants to this study need to be diagnosed with multiple sclerosis and aged between 21-55. Approximately 50 contenders are currently being recruited for the trial."
Answered by AI
Are adults of any age eligible to join this clinical experiment?
"This research project is looking for participants ranging between 21 and 55 years old."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
Robert Wood Johnson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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