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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
37
Commercially available Prebiotin Prebiotic. 2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)
Commercially available Probiotics Visbiome extra strength, which is a combination of live lactic acid bacteria probiotics that have been cultivated, freeze-dried and mixed in very high concentrations. 2 packets (450 billion CFU), Twice Daily (Total of 3,600 billion Daily)
Columbia University Irving Medical Center
New York, New York, United States
University of Pittsburg
Pittsburgh, Pennsylvania, United States
Change in Peripheral Blood Mononuclear Cells (pBMCs)
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.
Time frame: Up to 24 weeks
Change in Serum Neurofilament Light Concentration
Change in serum neurofilament light concentration post-supplementation as compared to baseline. Serum neurofilament light (NfL) will be measured in terms of pg/ML.
Time frame: Up to 24 weeks
Change in relative abundance of gut microbiome
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.
Time frame: Up to 24 weeks
Modified Fatigue Impact Scale
Modified Fatigue Impact Scale assesses fatigue effects in terms of physical, cognitive, and psychosocial functioning. The total core ranges from 0 - 20 (5 item version). Higher scores suggest a greater impact of fatigue on a patient's activities.
Time frame: Up to 24 weeks
Bowel Control Scale
Bowel Control Scale measures the impact of bowel control on lifestyle. The total score range from 0 - 26 (5 item version). Higher scores indicate greater bowel control issues.
Time frame: Up to 24 weeks
Patient Determined Disease Steps
Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).
Time frame: Up to 24 weeks
Multiple Sclerosis Rating Scale
Multiple Sclerosis Rating Scale - Revised evaluates functional status to identify disability in domains other than walking. Scores range from 0 (normal status) to 4 (severe disability).
Time frame: Up to 24 weeks
Patient Health Questionnaire
Patient Health Questionnaire helps identify symptoms that could be related to depression. The total score ranges from 0 (None) to 27 (Severe).
Time frame: Up to 24 weeks
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