Trial Outcomes & Findings for HFS (High-Fiber Supplement) in MS (Multiple Sclerosis) (NCT NCT04574024)
NCT ID: NCT04574024
Last Updated: 2024-12-17
Results Overview
TNF-alpha is involved in MS pathology, therefore, we examined the serum level of TNF-alpha by Luminex multiplex assay.
COMPLETED
PHASE1/PHASE2
7 participants
Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
2024-12-17
Participant Flow
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
Participant milestones
| Measure |
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)
|
|---|---|
|
Baseline
STARTED
|
7
|
|
Baseline
COMPLETED
|
7
|
|
Baseline
NOT COMPLETED
|
0
|
|
NBT-NM108 Treatment for 8 Weeks
STARTED
|
3
|
|
NBT-NM108 Treatment for 8 Weeks
COMPLETED
|
3
|
|
NBT-NM108 Treatment for 8 Weeks
NOT COMPLETED
|
0
|
|
NBT-NM108 Treatment for 12 Weeks
STARTED
|
2
|
|
NBT-NM108 Treatment for 12 Weeks
COMPLETED
|
2
|
|
NBT-NM108 Treatment for 12 Weeks
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)
Baseline characteristics by cohort
| Measure |
Study Cohort
n=7 Participants
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)
|
|---|---|
|
Age, Customized
|
46.4 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
|
MS medication at Baseline
|
2 Participants
n=5 Participants
|
|
Treatment naive
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
TNF-alpha is involved in MS pathology, therefore, we examined the serum level of TNF-alpha by Luminex multiplex assay.
Outcome measures
| Measure |
Baseline
n=3 Participants
MS patients who did not consume or before the start of NBT-NM108 treatment.
|
NBT-NM108 Treatment for 8 Weeks.
n=3 Participants
Three MS patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks.
|
NBT-NM108 Treatment for 12 Weeks
n=2 Participants
Two MS patients further consumed the NBT-NM108 for more 4 weeks (total 12 weeks)
|
|---|---|---|---|
|
Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients
|
25.62 pg/ml
Standard Error 1.28
|
22.58 pg/ml
Standard Error 0.78
|
20.73 pg/ml
Standard Error 0.56
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Baseline
n=7 Participants
MS patients who did not consume or before the start of NBT-NM108 treatment.
|
NBT-NM108 Treatment for 8 Weeks.
n=3 Participants
Three MS patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks.
|
NBT-NM108 Treatment for 12 Weeks
n=2 Participants
Two MS patients further consumed the NBT-NM108 for more 4 weeks (total 12 weeks)
|
|---|---|---|---|
|
Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.
|
1.94 % abundance
Standard Error 0.89
|
4.23 % abundance
Standard Error 0.52
|
4.52 % abundance
Standard Error 0.35
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Baseline
n=7 Participants
MS patients who did not consume or before the start of NBT-NM108 treatment.
|
NBT-NM108 Treatment for 8 Weeks.
n=3 Participants
Three MS patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks.
|
NBT-NM108 Treatment for 12 Weeks
n=2 Participants
Two MS patients further consumed the NBT-NM108 for more 4 weeks (total 12 weeks)
|
|---|---|---|---|
|
Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients
|
68.7 ng/mg
Standard Error 30.9
|
24.4 ng/mg
Standard Error 3.8
|
33.4 ng/mg
Standard Error 2.7
|
Adverse Events
MS Study Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Suhayl Dhib-Jalbut
Rutgers, The State University of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place