Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Columbia University
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Change in relative abundance of gut microbiome
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in relative abundance of gut microbiome
Time Frame: 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
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)