Prebiotic vs Probiotic in Multiple Sclerosis (MS)

Columbia University

Status: Completed

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome (CIS)

Treatments: Dietary Supplement: Probiotics (Visbiome®); Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)

Study type: Interventional

Funder types: Other

Identifiers

NCT04038541

AAAR9614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Prebiotic/ Probiotic

Other group

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).

Treatment:

Dietary Supplement: Probiotics (Visbiome®)

Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)

Probiotic/ Prebiotic

Other group

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).

Treatment:

Dietary Supplement: Probiotics (Visbiome®)

Dietary Supplement: Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)