Multiple Sclerosis
Conditions
Keywords
High-fiber supplement
Brief 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.
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.
Interventions
DRUGNBT-NM108
MS Patients received NBT-NM108 at 60 g/day.
Sponsors
Suhayl Dhib-Jalbut, MD
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
High-fiber supplement-treatment and non-treatment
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients | 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. | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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) | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Study Cohort |
|---|---|
| Age, Customized | 46.4 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| MS medication at Baseline | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
| Treatment naive | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients | 25.62 pg/ml | Standard Error 1.28 |
| NBT-NM108 Treatment for 8 Weeks. | Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients | 22.58 pg/ml | Standard Error 0.78 |
| NBT-NM108 Treatment for 12 Weeks | Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients | 20.73 pg/ml | Standard Error 0.56 |
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.
Time frame: Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients | 68.7 ng/mg | Standard Error 30.9 |
| NBT-NM108 Treatment for 8 Weeks. | Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients | 24.4 ng/mg | Standard Error 3.8 |
| NBT-NM108 Treatment for 12 Weeks | Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients | 33.4 ng/mg | Standard Error 2.7 |
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.
Time frame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients. | 1.94 % abundance | Standard Error 0.89 |
| NBT-NM108 Treatment for 8 Weeks. | Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients. | 4.23 % abundance | Standard Error 0.52 |
| NBT-NM108 Treatment for 12 Weeks | Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients. | 4.52 % abundance | Standard Error 0.35 |