CompletedPhase 1/2

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

United States7 participantsStarted 2022-03-21

Plain-language 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.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients

Timeframe: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.

Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.

Timeframe: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.

Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients

Timeframe: Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.

Trial details

NCT IDNCT04574024

SponsorSuhayl Dhib-Jalbut, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

Results submitted2024-07-29

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients

Timeframe: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.

Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.

Timeframe: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.

Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients

Timeframe: Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.