Clinical trial NCT04574024: HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)
Official title: Effect of High-fiber Supplement in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: High-fiber supplement
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: High-fiber supplement-treatment and non-treatment
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients
timeFrame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
measure: Examine the Effect of NBT-NM108 on Anaerostipes in MS Patients.
timeFrame: Baseline; and 8 weeks and 12 weeks post-NBT-NM108 treatment.
measure: Effect of NBT-NM108 on Fecal Lcn-2 Levels in MS Patients
timeFrame: Baseline, and 8 weeks and 12 weeks post-NBT-NM108 treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Suhayl Dhib-Jalbut, MD
role: PRINCIPAL_INVESTIGATOR
References: