Multiple SclerosisPhase 1/2NCT04574024
HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)
A Phase 1/2 study testing NBT-NM108 in people with Multiple Sclerosis, run by Suhayl Dhib-Jalbut, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- NBT-NM108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 15 Jul 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
Who cannot join
- Primary or secondary progressive MS.
- Patients with autoimmune comorbidities.
- Having received prior chemotherapy.
- Having received Dimethylfumarate (DMF).
- Pregnant women.
- Cognitively impaired.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- NBT-NM108
- Keywords
- High-fiber supplement
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBT-NM108Drug
MS Patients received NBT-NM108 at 60 g/day.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: NBT-NM108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start21 Mar 2022
- Primary completion30 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- High-fiber supplement-treatment and non-treatment
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suhayl Dhib-Jalbut, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suhayl Dhib-Jalbut, MD, Rutgers, The State University of New Jersey
- Investigators
- Suhayl Dhib-Jalbut, MD, Principal investigator, Rutgers-RWJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574024
- Sponsor's protocol ID
- Pro2019001677
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2020
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-fiber Supplement in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04574024
- Acronym / sponsor ID
- Pro2019001677
- Conditions
- Multiple Sclerosis
- Keywords
- High-fiber supplement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Suhayl Dhib-Jalbut, MDUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Posted 17 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- High-fiber supplement-treatment and non-treatment
| Arm | Type | Receives |
|---|---|---|
| MS study cohort | Other | Drug: NBT-NM108Baseline: 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
Key exclusion criteria (11 listed)
- Primary or secondary progressive MS.
- Patients with autoimmune comorbidities.
- Having received prior chemotherapy.
- Having received Dimethylfumarate (DMF).
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBT-NM108MS Patients received NBT-NM108 at 60 g/day. | Drug | MS study cohort |
Primary outcome
Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients
Time frame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
TNF-alpha is involved in MS pathology, therefore, we examined the serum level of TNF-alpha by Luminex multiplex assay.
Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.
Time frame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
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.
Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients
Time frame: Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhayl Dhib-Jalbut, MD principal investigator
Rutgers-RWJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NBT-NM108 in people with Multiple Sclerosis, run by Suhayl Dhib-Jalbut, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients (time frame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.