Skip to main content
OpenTrials
Completed

NCT Number: NCT04038541

Prebiotic vs Probiotic 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated Syndrome (CIS) Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Exegi Pharma
  • National Multiple Sclerosis Society

Registry information

Official study title

Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis

Acronym: MS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 31, 2019
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.