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Prebiotic vs Probiotic in Multiple Sclerosis

NCT04038541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • National Multiple Sclerosis Society

    collaborator OTHER

  • Exegi Pharma

    collaborator UNKNOWN

  • Columbia University

    lead OTHER

Principal Investigators

  • Rebecca Farber, MD · Columbia University

  • Zongqi Xia, MD · University of Pittsburgh (Collaborator Site)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038541 on ClinicalTrials.gov