Clinical trial NCT04038541: Prebiotic vs Probiotic in Multiple Sclerosis
Official title: Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Clinically Isolated Syndrome (CIS)
Keywords: Prebiotics
Probiotics
Gut microbiome
Multiple Sclerosis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Exegi Pharma
First posted: 2019-07-31
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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:

  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

Primary outcomes:
measure: Change in Peripheral Blood Mononuclear Cells (pBMCs)
timeFrame: Up to 24 weeks
measure: Change in Serum Neurofilament Light Concentration
timeFrame: Up to 24 weeks
measure: Change in relative abundance of gut microbiome
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: Up to 24 weeks
measure: Bowel Control Scale
timeFrame: Up to 24 weeks
measure: Patient Determined Disease Steps
timeFrame: Up to 24 weeks
measure: Multiple Sclerosis Rating Scale
timeFrame: Up to 24 weeks
measure: Patient Health Questionnaire
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburg
state: Pennsylvania
Study officials:
affiliation: Columbia University
name: Rebecca Farber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh (Collaborator Site)
name: Zongqi Xia, MD
role: PRINCIPAL_INVESTIGATOR
References: