Status:
COMPLETED
Prebiotic vs Probiotic in Multiple Sclerosis
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Multiple Sclerosis Society
Exegi Pharma
Conditions:
Multiple Sclerosis
Clinically Isolated Syndrome (CIS)
Eligibility:
All Genders
18+ years
Phase:
NA
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 patie...
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. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04038541
Start Date
March 11 2020
End Date
December 30 2023
Last Update
May 22 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
2
University of Pittsburg
Pittsburgh, Pennsylvania, United States, 15260