Effect of High-fiber Supplement in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
排除标准
- •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.
研究组 & 干预措施
MS study cohort
Baseline: 7 MS patients enrolled for the study. No treatment or before treatment.
NBT-NM108-Treatment for 8 weeks: 3 out of 7 MS patients consumed the NBT-NM108 for 8 weeks.
NBT-NM108-Treatment for 12 weeks: 2 MS patients further consumed the NBT-NM108 for four more weeks.
Patients consumed dietary fiber three times a day at 60 g/day
干预措施: NBT-NM108 (Drug)
结局指标
主要结局
Assess the Effect of NBT-NM108 on Serum TNF-alpha Levels in MS Patients
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Suhayl Dhib-Jalbut, MD
Professor of Neurology
Rutgers, The State University of New Jersey