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Prebiotics vs Probiotics for Multiple Sclerosis (MS Trial)
N/A
Recruiting
Led By Rebecca Farber, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
MS Trial Summary
This trial is exploring the immunologic effects of Prebiotics vs Probiotics in MS and CIS patients. Patients will take each supplement for 6 weeks with a 6-week washout period in between.
Eligible Conditions
- Multiple Sclerosis
- Clinically Isolated Syndrome
MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Peripheral Blood Mononuclear Cells (pBMCs)
Change in Serum Neurofilament Light Concentration
Change in relative abundance of gut microbiome
Secondary outcome measures
Bowel Control Scale
Modified Fatigue Impact Scale
Multiple Sclerosis Rating Scale
+2 moreMS Trial Design
2Treatment groups
Experimental Treatment
Group I: Probiotic/ PrebioticExperimental Treatment2 Interventions
These subjects will be assigned to first receive probiotics (Visbiome®) for 6 weeks. Then after a 6 week wash-out period, subjects will take (Prebiotin Prebiotic Fiber Stick) for 6 weeks (followed again by a 6 week washout period).
Group II: Prebiotic/ ProbioticExperimental Treatment2 Interventions
These subjects will be assigned to first receive prebiotics (Prebiotin Prebiotic Fiber Stick Pac) for 6 weeks. Then after a 6 week wash-out period, subjects will take probiotics (Visbiome®) for 6 weeks (followed again by a 6 week washout period).
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Who is running the clinical trial?
Exegi PharmaUNKNOWN
National Multiple Sclerosis SocietyOTHER
95 Previous Clinical Trials
9,463 Total Patients Enrolled
93 Trials studying Multiple Sclerosis
9,109 Patients Enrolled for Multiple Sclerosis
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,811 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
5,705 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a recurrence of your condition within the last 3 months.Adults diagnosed with MS or CIS within the last 10 years.You have taken steroids within the 4 weeks before the study starts.You have taken antibiotics within the last 3 months before joining the study.You have taken prebiotics or probiotics daily in the 3 months before enrolling in the study.You have had a large part of your bowel removed.You have taken any of the following drugs before: Mycophenolate/CellCept, Cyclophosphamide/Cytoxan, Methotrexate/Novantrone, Azathioprine/Imuran, Cladribine/Leustatin/Mavenclad, Daclizumab/Zenapax, Alemtuzumab/Campath/Lemtrada.You have been diagnosed with certain autoimmune disorders like Rheumatoid Arthritis, Lupus, Celiac disease, and others.You are currently taking rituximab or ocrelizumab for treatment.Criterion: You have any of the following active uncontrolled gastrointestinal (GI) illnesses: Crohn's disease, ulcerative colitis, indeterminate colitis, moderate to severe irritable bowel syndrome, persistent or chronic diarrhea of unknown cause, severe chronic constipation, ongoing infectious gastroenteritis, Clostridium difficile infection (recurrent), gastrointestinal or colonic malignancy, active use of bismuth subsalicylate-containing products, or are currently pregnant.Adults over 18 years old diagnosed with relapsing-remitting MS or CIS within the last 10 years.
Research Study Groups:
This trial has the following groups:- Group 1: Prebiotic/ Probiotic
- Group 2: Probiotic/ Prebiotic
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants that can be enrolled in this investigation?
"Correct. The particulars of this clinical trial are available on the website clinicaltrials.gov, which states that recruitment is in progress for the study that was initially posted on March 11th 2020. Notably, 20 participants must be sourced from two medical centres by 3/15/2023."
Answered by AI
What goals are researchers attempting to accomplish through this experiment?
"This 24-week trial will monitor the alterations in gut microbiome composition. Secondary endpoints involve assessments of physical disability, fatigue severity, and general functional status through Patient Determined Disease Steps, Modified Fatigue Impact Scale, and Multiple sclerosis Rating Scale - Revised measurements respectively."
Answered by AI
Is recruitment still open for this trial?
"Affirmative. Clinicaltrials.gov has information indicating that this trial is actively recruiting participants; it first appeared on March 11th 2020 and was recently updated on March 15th 2023. The study requires the enrolment of 20 patients from two medical centres."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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