Prebiotic vs Probiotic in Multiple Sclerosis

Completed · Not applicable

Conditions studied: Multiple Sclerosis, Clinically Isolated Syndrome (CIS)

In brief

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.

Key facts

Study ID

NCT04038541

Run by

Columbia University

People needed

37

Starts

2020-03-11

Expected to finish

2023-12-30

Last updated by the study team

2024-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States
• University of Pittsburg — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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