Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Change in relative abundance of gut microbiome
研究概览
简要总结
This is a randomized crossover-designed study to explore the immunologic effects of Prebiotics, as opposed to direct supplementation with beneficial bacteria (Probiotics) in the immune system of patients with MS and Clinically Isolated Syndrome (CIS). Eligible patients will take 6 weeks of two different supplements - Prebiotics and Probiotics. Participants will be randomly assigned to take either of two agents for 6 weeks as their first supplement. Then, participants enter a 6-week washout period. After the washout period, participants will take the second supplement for 6 weeks. After taking the second supplement, participants will have a 6-week washout period.
详细描述
Soluble fibers (prebiotics) are fermented by beneficial bacteria (probiotics) in the colon to produce short-chain fatty acids (SCFAs) which are the main source of nutrition for the cells in the gut. It has been reported that the fermentable fiber inulin and SCFAs may exert some beneficial effects including anti-inflammatory effect on the immune system. To date, the effect of supplementation with fermentable dietary fiber, such as prebiotics in patients with Multiple Sclerosis (MS) has not been investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 18 or older) diagnosed with MS (Relapsing-remitting type) or CIS and recruited within 10 years of symptom onset, and
- •Adult patients receiving anti-CD20 therapy (rituximab or ocrelizumab) who have received at least one cycle at the time of recruitment
排除标准
- •Active relapse within 3 months of enrollment
- •Steroid use within 4 weeks of enrollment
- •Antibiotics use within 3 months of enrollment
- •Daily pre or prebiotic use within 3 months of enrollment
- •Diagnosed with any of the autoimmune disorders: Rheumatoid Arthritis, Lupus, Celiac disease, Vitiligo, Psoriasis, Psoriatic Arthritis, Hashimoto's Thyroiditis, Graves' Disease, Sjogren's syndrome, Type 1 Diabetes, Scleroderma, Crohn's Disease, Ulcerative Colitis, Alopecia Areata.
- •Had surgery of the GI tract in the last 5 years (with the exception of cholecystectomy and appendectomy)
- •Had a major bowel resection
- •Prior use of any of the following drugs: Mycophenolate/Cellcept, Cyclophosphamide/Cytoxan, Methotrexate/Novantrone, Azathioprine/Imuran, Cladribine/Leustatin/Mavenclad, Daclizumab/Zenepax, Alemtuzumab/Campath/Lemtrada
- •Have any of the following active uncontrolled gastrointestinal (GI) illnesses:
- •Crohn's disease, ulcerative colitis, indeterminate colitis
- •Irritable bowel syndrome: moderate-severe
- •Persistent or chronic diarrhea of unknown etiology
- •Severe Chronic constipation or difficulties with defecation
- •Persistent, infectious gastroenteritis, colitis or gastritis
- •Clostridium difficile infection (recurrent)
- •Gastric or intestinal ulcerations/GI bleeding
- •Gastrointestinal or colonic malignancy: polyps, masses, dysplasia or cancer
- •Active use of bismuth subsalicylate-containing products
- •Currently pregnant
结局指标
主要结局
Change in relative abundance of gut microbiome
时间窗: Up to 24 weeks
Changes in the gut microbiota in stool samples will be assessed as percent relative abundance at the genus level post supplementation as compared to baseline. Gut microbiota will be identified by extracting bacterial DNA from stool samples and performing metagenome shotgun sequencing.
Change in Serum Neurofilament Light Concentration
时间窗: Up to 24 weeks
Change in serum neurofilament light concentration post-supplementation as compared to baseline. Serum neurofilament light (NfL) will be measured in terms of pg/ML.
Change in Peripheral Blood Mononuclear Cells (pBMCs)
时间窗: Up to 24 weeks
Measure the number of differentially expressed probe sets in the pBMCs post-supplementation, as compared to subject baseline. Probe sets will count as differentially expressed based on a threshold of pBH \<0.05 and a Fold Change (FC) \> ±2.
次要结局
- Modified Fatigue Impact Scale(Up to 24 weeks)
- Patient Health Questionnaire(Up to 24 weeks)
- Multiple Sclerosis Rating Scale(Up to 24 weeks)
- Bowel Control Scale(Up to 24 weeks)
- Patient Determined Disease Steps(Up to 24 weeks)