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Prebiotic vs Probiotic in Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis, Clinically Isolated Syndrome (CIS)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)
Probiotics (Visbiome®)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Prebiotics, Probiotics, Gut microbiome, Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting
  • University of PittsburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Prebiotic/ Probiotic

Probiotic/ Prebiotic

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Patient Determined Disease Steps
Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).
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).
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).

Full Information

First Posted
June 7, 2019
Last Updated
March 15, 2023
Sponsor
Columbia University
Collaborators
National Multiple Sclerosis Society, Exegi Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04038541
Brief Title
Prebiotic vs Probiotic in Multiple Sclerosis
Acronym
MS
Official Title
Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Multiple Sclerosis Society, Exegi Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Clinically Isolated Syndrome (CIS)
Keywords
Prebiotics, Probiotics, Gut microbiome, Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic/ Probiotic
Arm Type
Other
Arm Description
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).
Arm Title
Probiotic/ Prebiotic
Arm Type
Other
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)
Intervention Description
Commercially available Prebiotin Prebiotic. 2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics (Visbiome®)
Intervention Description
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 Measure Information:
Title
Change in Peripheral Blood Mononuclear Cells (pBMCs)
Description
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.
Time Frame
Up to 24 weeks
Title
Change in Serum Neurofilament Light Concentration
Description
Change in serum neurofilament light concentration post-supplementation as compared to baseline. Serum neurofilament light (NfL) will be measured in terms of pg/ML.
Time Frame
Up to 24 weeks
Title
Change in relative abundance of gut microbiome
Description
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.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Modified Fatigue Impact Scale
Description
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.
Time Frame
Up to 24 weeks
Title
Bowel Control Scale
Description
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.
Time Frame
Up to 24 weeks
Title
Patient Determined Disease Steps
Description
Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).
Time Frame
Up to 24 weeks
Title
Multiple Sclerosis Rating Scale
Description
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).
Time Frame
Up to 24 weeks
Title
Patient Health Questionnaire
Description
Patient Health Questionnaire helps identify symptoms that could be related to depression. The total score ranges from 0 (None) to 27 (Severe).
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Farber, MD
Phone
212-305-6876
Email
mscenter_neuro@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaho Onomichi, MS
Phone
212-305-9155
Email
ko2418@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Farber, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zongqi Xia, MD
Organizational Affiliation
University of Pittsburgh (Collaborator Site)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaho Onomichi, MS
Phone
212-305-9155
Email
ko2418@cumc.columbia.edu
Facility Name
University of Pittsburg
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongqi Xia, MD
First Name & Middle Initial & Last Name & Degree
Wen Zhu
Email
w.zhu@pitt.edu
First Name & Middle Initial & Last Name & Degree
Zongqi Xia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Prebiotic vs Probiotic in Multiple Sclerosis

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