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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBT-NM108 | Drug | MS Patients received NBT-NM108 at 60 g/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suhayl Dhib-Jalbut, MD | Rutgers-RWJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
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Baseline data was collected from 7 MS patients enrolled in this study. Three out of seven MS patients consumed NBT-NM108 for 8 weeks. Two out of the three MS patients continued the NBT-NM108 treatment for more 4 weeks (total 12 weeks). Stool and blood samples were collected at 3 time points (baseline, 8 week post-NBT-NM108 , and 12 week post-NBT-NM108 ).
Baseline: 7, 8 weeks post- NBT-NM108 : 3, 12 weeks post- NBT-NM108 : 2
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| ID | Title | Description |
|---|---|---|
| FG000 | MS Study Cohort | 7 MS patients enrolled in this study. Three out of seven MS patients consumed NBT-NM108 for 8 weeks. Two out of the three MS patients continued the NBT-NM108 treatment for more 4 weeks (total 12 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| NBT-NM108 Treatment for 8 Weeks |
| |||||||||||||
| NBT-NM108 Treatment for 12 Weeks |
|
7 MS patients enrolled in this study. Baseline data was collected from 7 MS patients. Three out of seven MS patients consumed NBT-NM108 for 8 weeks. Two out of the three MS patients continued the NBT-NM108 treatment for more 4 weeks (total 12 weeks)
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Cohort | 7 MS patients enrolled in this study. Baseline data was collected from 7 MS patients. Three out of seven MS patients consumed NBT-NM108 for 8 weeks. Two out of the three MS patients continued the NBT-NM108 treatment for more 4 weeks (total 12 weeks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Three MS patients consumed dietary fiber three times a day at 60 g/day for 8 weeks. Two out of the three MS patients continued NBT-NM108 treatment for more 4 weeks (total12 weeks). Blood samples were collected at 3 time points (baseline, 8 week post-NBT-NM108, and 12 week post-NBT-NM108). | Posted | Mean | Standard Error | pg/ml | Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment. |
|
A nurse from the research team followed up with MS patients by phone at the end of the first week after intervention to check the compliance and adverse effects and then every month thereafter, up to 30 days after the last dose of study intervention. Dr. Suhyal Dhib-Jalbut informed consent to participants and recorded all events from treatment-start date until -end date.
Adverse events were determined based on the FDA guidelines 21CFR312.32.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MS Study Cohort | 7 MS patients enrolled in this study. Baseline data was collected from 7 MS patients. Three out of seven MS patients consumed NBT-NM108 for 8 weeks. Two out of the three MS patients continued the NBT-NM108 treatment for more 4 weeks (total 12 weeks) |
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We were unable to enroll proposed number of MS patients due to the COVID pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suhayl Dhib-Jalbut | Rutgers, The State University of New Jersey | 732-235-7335 | jalbutsu@rwjms.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2023 | Sep 10, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2023 | Jul 24, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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High-fiber supplement-treatment and non-treatment
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| MS medication at Baseline | This measurement indicate the number of participants using MS medication at the time of recruitment. | Count of Participants | Participants |
|
| Treatment naive | Count of Participants | Participants |
|
Three MS patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks. |
| OG002 | NBT-NM108 Treatment for 12 Weeks | Two MS patients further consumed the NBT-NM108 for more 4 weeks (total 12 weeks) |
|
|
| Primary | 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 data was collected from seven MS patients. Three out of seven MS patients consumed dietary fiber three times a day at 60 g/day for 8 weeks. Two out of the three MS patients continued the HFS treatment for more 4 weeks (total 12 weeks). Stool samples were collected at 3 time points (baseline, 8 week post- NBT-NM108, and 12 week post- NBT-NM108). | Posted | Mean | Standard Error | % abundance | Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment. |
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| Primary | 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 data was collected from seven MS patients. Three out of seven MS patients consumed dietary fiber three times a day at 60 g/day for 8 weeks. Two out of the three MS patients continued the HFS treatment for more 4 weeks (total 12 weeks). Stool samples were collected at 3 time points (baseline, 8 week post- NBT-NM108, and 12 week post- NBT-NM108). | Posted | Mean | Standard Error | ng/mg | Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment. |
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| 0 |
| 7 |
| 0 |
| 7 |
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| 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |