CompletedNot a drug-phase studyRelapsing MSNCT04038541

What it found

Result in a paper, not read yet

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 markers
  • Change in relative abundance of gut microbiome

    Up to 24 weeks

Other measures (5)

  • Modified Fatigue Impact Scale

    Up to 24 weeks

    Thinking and memoryFatigue
  • Bowel Control Scale

    Up to 24 weeks

    Bladder, bowel and sexual function
  • Patient Determined Disease Steps

    Up to 24 weeks

    Walking and mobility
  • Multiple Sclerosis Rating Scale

    Up to 24 weeks

    Walking and mobility
  • Patient 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

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Related trials

History

    1. Started

      Mar 2020

    2. Main results due

      Dec 2023

    3. Finished

      Dec 2023

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