HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)
Effect of High-fiber Supplement in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- NBT-NM108
Results by group
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.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 25.62 pg/ml | 1.28 (Standard Error) | 3 |
| NBT-NM108 Treatment for 8 Weeks. | 22.58 pg/ml | 0.78 (Standard Error) | 3 |
| NBT-NM108 Treatment for 12 Weeks | 20.73 pg/ml | 0.56 (Standard Error) | 2 |
Baseline
NBT-NM108 Treatment for 8 Weeks.
NBT-NM108 Treatment for 12 Weeks
Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.
Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 1.94 % abundance | 0.89 (Standard Error) | 7 |
| NBT-NM108 Treatment for 8 Weeks | 4.23 % abundance | 0.52 (Standard Error) | 3 |
| NBT-NM108 Treatment for 12 Weeks | 4.52 % abundance | 0.35 (Standard Error) | 2 |
Baseline
NBT-NM108 Treatment for 8 Weeks
NBT-NM108 Treatment for 12 Weeks
Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients
Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline | 68.7 ng/mg | 30.9 (Standard Error) | 7 |
| NBT-NM108 Treatment for 8 Weeks | 24.4 ng/mg | 3.8 (Standard Error) | 3 |
| NBT-NM108 Treatment for 12 Weeks | 33.4 ng/mg | 2.7 (Standard Error) | 2 |
Baseline
NBT-NM108 Treatment for 8 Weeks
NBT-NM108 Treatment for 12 Weeks
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| MS Study Cohort | 7 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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.
Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.
Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients
Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Who could take part
Relapsing MS · 21 to 55
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Mar 2022
Main results due
Jun 2024
Finished
Jul 2024
Results posted
Dec 2024