Phase 2
N=7
HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04574024 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients — 25.62; 22.58; 20.73 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NBT-NM108 (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Suhayl Dhib-Jalbut, MD
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients |
25.62; 22.58; 20.73 | — |
| PRIMARY Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients. |
1.94; 4.23; 4.52 | — |
| PRIMARY Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients |
68.7; 24.4; 33.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
Exclusion Criteria
- Primary or secondary progressive MS.
- Patients with autoimmune comorbidities.
- Having received prior chemotherapy.
- Having received Dimethylfumarate (DMF).
- Pregnant women.
- Cognitively impaired.
- 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.
Data sourced from ClinicalTrials.gov (NCT04574024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.