Multiple SclerosisMSNCT04038541
Prebiotic vs Probiotic in Multiple Sclerosis
A study testing Prebiotics (Prebiotin Prebiotic Fiber Stick Pac) and Probiotics (Visbiome®) in people with Multiple Sclerosis and Clinically Isolated Syndrome (CIS), run by Columbia University at 2 sites in United States.
Trial 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 patients with MS and Clinically Isolated Syndrome (CIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome (CIS)
- What is being tested?
- Prebiotics (Prebiotin Prebiotic Fiber Stick Pac) and Probiotics (Visbiome®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Irving Medical Center
New York, New York, 10032
University of Pittsburg
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
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.
Read the 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. It has been reported that the fermentable fiber inulin and SCFAs may exert some beneficial effects including anti-inflammatory effect on the immune system. To date, the effect of supplementation with fermentable dietary fiber, such as prebiotics in patients with Multiple Sclerosis (MS) has not been investigated.
- Being tested
- Prebiotics (Prebiotin Prebiotic Fiber Stick Pac), Probiotics (Visbiome®)
- Keywords
- Prebiotics, Probiotics, Gut microbiome, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)Dietary supplement
Commercially available Prebiotin Prebiotic.
2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)
Probiotics (Visbiome®)Dietary supplement
Commercially available Probiotics Visbiome extra strength, which is a combination of live lactic acid bacteria probiotics that have been cultivated, freeze-dried and mixed in very high concentrations.
2 packets (450 billion CFU), Twice Daily (Total of 3,600 billion Daily)
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic/ Probiotic | Other | 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). Receives: Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac); Dietary Supplement: Probiotics (Visbiome®) |
| Probiotic/ Prebiotic | Other | 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). Receives: Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac); Dietary Supplement: Probiotics (Visbiome®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peripheral Blood Mononuclear Cells (pBMCs)
Measure the number of differentially expressed probe sets in the pBMCs post-supplementation, as compared to subject baseline. Probe sets will count as differentially expressed based on a threshold of pBH <0.05 and a Fold Change (FC) > ±2.
Measured: Up to 24 weeks
Change in Serum Neurofilament Light Concentration
Change in serum neurofilament light concentration post-supplementation as compared to baseline. Serum neurofilament light (NfL) will be measured in terms of pg/ML.
Measured: Up to 24 weeks
Change in relative abundance of gut microbiome
Changes in the gut microbiota in stool samples will be assessed as percent relative abundance at the genus level post supplementation as compared to baseline. Gut microbiota will be identified by extracting bacterial DNA from stool samples and performing metagenome shotgun sequencing.
Measured: Up to 24 weeks
Secondary outcomes (5)
Modified Fatigue Impact Scale
Modified Fatigue Impact Scale assesses fatigue effects in terms of physical, cognitive, and psychosocial functioning. The total core ranges from 0 - 20 (5 item version). Higher scores suggest a greater impact of fatigue on a patient's activities.
Measured: Up to 24 weeks
Bowel Control Scale
Bowel Control Scale measures the impact of bowel control on lifestyle. The total score range from 0 - 26 (5 item version). Higher scores indicate greater bowel control issues.
Measured: Up to 24 weeks
Patient Determined Disease Steps
Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).
Measured: Up to 24 weeks
Multiple Sclerosis Rating Scale
Multiple Sclerosis Rating Scale - Revised evaluates functional status to identify disability in domains other than walking. Scores range from 0 (normal status) to 4 (severe disability).
Measured: Up to 24 weeks
Patient Health Questionnaire
Patient Health Questionnaire helps identify symptoms that could be related to depression. The total score ranges from 0 (None) to 27 (Severe).
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start11 Mar 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, interventional trial with a crossover design, in which participants will be taking either probiotic (commercially available Visbiome) or prebiotic (prebiotin prebiotic) for 6 weeks as the first agent. Then, participants enter a 6-week washout period. After the washout period, participants take the second agent for 6 weeks. After taking the second agent, participants again have a 6-week wash-out period.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Exegi Pharma
- Responsible party
- Sponsor
- Investigators
- Rebecca Farber, MD, Principal investigator, Columbia UniversityZongqi Xia, MD, Principal investigator, University of Pittsburgh (Collaborator Site)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038541
- Sponsor's protocol ID
- AAAR9614
- Acronym
- MS
- Status last verified
- May 2024
- First submitted
- 7 Jun 2019
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04038541
- Acronym / sponsor ID
- MS / AAAR9614
- Keywords
- Prebiotics, Probiotics, Gut microbiome, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Exegi Pharma
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. It has been reported that the fermentable fiber inulin and SCFAs may exert some beneficial effects including anti-inflammatory effect on the immune system. To date, the effect of supplementation with fermentable dietary fiber, such as prebiotics in patients with Multiple Sclerosis (MS) has not been investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, interventional trial with a crossover design, in which participants will be taking either probiotic (commercially available Visbiome) or prebiotic (prebiotin prebiotic) for 6 weeks as the first agent. Then, participants enter a 6-week washout period. After the washout period, participants take the second agent for 6 weeks. After taking the second agent, participants again have a 6-week wash-out period.
| Arm | Type | Receives |
|---|---|---|
| Prebiotic/ Probiotic | Other | Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac), Dietary Supplement: Probiotics (Visbiome®)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). |
| Probiotic/ Prebiotic | Other | Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac), Dietary Supplement: Probiotics (Visbiome®)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)Commercially available Prebiotin Prebiotic. 2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily) | Dietary supplement | Prebiotic/ Probiotic, Probiotic/ Prebiotic |
| Probiotics (Visbiome®)Commercially available Probiotics Visbiome extra strength, which is a combination of live lactic acid bacteria probiotics that have been cultivated, freeze-dried and mixed in very high concentrations. 2 packets (450 billion CFU), Twice Daily (Total of 3,600 billion Daily) | Dietary supplement | Prebiotic/ Probiotic, Probiotic/ Prebiotic |
Primary outcome
Change in Peripheral Blood Mononuclear Cells (pBMCs)
Time frame: Up to 24 weeks
Measure the number of differentially expressed probe sets in the pBMCs post-supplementation, as compared to subject baseline. Probe sets will count as differentially expressed based on a threshold of pBH <0.05 and a Fold Change (FC) > ±2.
Change in Serum Neurofilament Light Concentration
Time frame: Up to 24 weeks
Change in serum neurofilament light concentration post-supplementation as compared to baseline. Serum neurofilament light (NfL) will be measured in terms of pg/ML.
Change in relative abundance of gut microbiome
Time frame: Up to 24 weeks
Changes in the gut microbiota in stool samples will be assessed as percent relative abundance at the genus level post supplementation as compared to baseline. Gut microbiota will be identified by extracting bacterial DNA from stool samples and performing metagenome shotgun sequencing.
5 secondary outcomes
Modified Fatigue Impact Scale
Time frame: Up to 24 weeks
Bowel Control Scale
Time frame: Up to 24 weeks
Patient Determined Disease Steps
Time frame: Up to 24 weeks
Multiple Sclerosis Rating Scale
Time frame: Up to 24 weeks
Patient Health Questionnaire
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Farber, MD principal investigator
Columbia University
Zongqi Xia, MD principal investigator
University of Pittsburgh (Collaborator Site)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotics (Prebiotin Prebiotic Fiber Stick Pac) and Probiotics (Visbiome®) in people with Multiple Sclerosis and Clinically Isolated Syndrome (CIS), run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral Blood Mononuclear Cells (pBMCs) (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.