Prebiotic vs Probiotic in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Clinically Isolated Syndrome (CIS); Multiple Sclerosis
• Interventions: Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac); Dietary Supplement: Probiotics (Visbiome®)

• Registration Number: NCT04038541
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-31
• Study Start: 2020-03-11
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prebiotic/ Probiotic	Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)	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	Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)	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).
Prebiotic/ Probiotic	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	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).

Primary Outcome Measures

Name	Time	Method
Change in relative abundance of gut microbiome	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.
Change in Serum Neurofilament Light Concentration	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 Peripheral Blood Mononuclear Cells (pBMCs)	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.

Secondary Outcome Measures

Name	Time	Method
Modified Fatigue Impact Scale	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.
Patient Health Questionnaire	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).
Multiple Sclerosis Rating Scale	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).
Bowel Control Scale	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.
Patient Determined Disease Steps	Up to 24 weeks	Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).

Trial Locations

Locations (2)

University of Pittsburg; 🇺🇸 Pittsburgh, Pennsylvania, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States