MS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)
- Probiotics (Visbiome®)
What it measured
Main measures
Change in Peripheral Blood Mononuclear Cells (pBMCs)
Up to 24 weeks
Change in Serum Neurofilament Light Concentration
Up to 24 weeks
Blood or spinal fluid markersChange in relative abundance of gut microbiome
Up to 24 weeks
Other measures (5)
Modified Fatigue Impact Scale
Up to 24 weeks
Thinking and memoryFatigueBowel Control Scale
Up to 24 weeks
Bladder, bowel and sexual functionPatient Determined Disease Steps
Up to 24 weeks
Walking and mobilityMultiple Sclerosis Rating Scale
Up to 24 weeks
Walking and mobilityPatient Health Questionnaire
Up to 24 weeks
Mood and sleep
Who could take part
Relapsing MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
A randomized cross-over trial of prebiotics and probiotics in multiple sclerosis: Trial feasibility, supplement tolerability and symptom abatement.Mult Scler Relat Disord · 2024
Loading reviews and guidelines…
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History
Started
Mar 2020
Main results due
Dec 2023
Finished
Dec 2023
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