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Trial record 1 of 1 for:    Visbiome | Multiple Sclerosis
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Prebiotic vs Probiotic in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT04038541
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Columbia University

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 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Clinically Isolated Syndrome (CIS) Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac) Dietary Supplement: Probiotics (Visbiome®) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Prebiotic/ Probiotic
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).
Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)

Commercially available Prebiotin Prebiotic.

2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)


Dietary Supplement: 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)


Probiotic/ Prebiotic
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).
Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)

Commercially available Prebiotin Prebiotic.

2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)


Dietary Supplement: 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)





Primary Outcome Measures :
  1. 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.

  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.

  3. 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.


Secondary Outcome Measures :
  1. Modified Fatigue Impact Scale [ Time Frame: Up to 24 weeks ]
    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.

  2. Bowel Control Scale [ Time Frame: Up to 24 weeks ]
    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.

  3. Patient Determined Disease Steps [ Time Frame: Up to 24 weeks ]
    Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).

  4. Multiple Sclerosis Rating Scale [ Time Frame: Up to 24 weeks ]
    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).

  5. Patient Health Questionnaire [ Time Frame: Up to 24 weeks ]
    Patient Health Questionnaire helps identify symptoms that could be related to depression. The total score ranges from 0 (None) to 27 (Severe).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038541


Contacts
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Contact: Rebecca Farber, MD 212-305-6876 mscenter_neuro@cumc.columbia.edu
Contact: Kaho Onomichi, MS 212-305-9155 ko2418@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kaho Onomichi, MS    212-305-9155    ko2418@cumc.columbia.edu   
United States, Pennsylvania
University of Pittsburg Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Zongqi Xia, MD         
Contact: Wen Zhu       w.zhu@pitt.edu   
Principal Investigator: Zongqi Xia, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Rebecca Farber, MD Columbia University
Principal Investigator: Zongqi Xia, MD University of Pittsburgh (Collaborator Site)

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT04038541    
Other Study ID Numbers: AAAR9614
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Columbia University:
Prebiotics
Probiotics
Gut microbiome
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases