Multiple Sclerosis Clinical Trial

Prebiotic vs Probiotic in Multiple Sclerosis

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.

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Full 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.

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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
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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

37

Study ID:

NCT04038541

Recruitment Status:

Completed

Sponsor:

Columbia University

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There are 2 Locations for this study

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Columbia University Irving Medical Center
New York New York, 10032, United States
University of Pittsburg
Pittsburgh Pennsylvania, 15260, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

37

Study ID:

NCT04038541

Recruitment Status:

Completed

Sponsor:


Columbia University

How clear is this clinincal trial information?

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