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Prebiotic vs Probiotic in Multiple Sclerosis

CompletedNA

Sponsor: Columbia University

Conditions: Multiple Sclerosis, Clinically Isolated Syndrome (CIS)

Interventions: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac), Probiotics (Visbiome®)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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:

1. Crohn's disease, ulcerative colitis, indeterminate colitis
2. Irritable bowel syndrome: moderate-severe
3. Persistent or chronic diarrhea of unknown etiology
4. Severe Chronic constipation or difficulties with defecation
5. Persistent, infectious gastroenteritis, colitis or gastritis
6. Clostridium difficile infection (recurrent)
7. Gastric or intestinal ulcerations/GI bleeding
8. Gastrointestinal or colonic malignancy: polyps, masses, dysplasia or cancer
* Active use of bismuth subsalicylate-containing products
* Currently pregnant

Locations (2)

New York, New York, United States
Pittsburgh, Pennsylvania, United States