Prebiotic vs Probiotic in Multiple Sclerosis

NCT04038541 | Completed

• 1 other identifier: AAAR9614
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Clinically Isolated Syndrome (CIS)

Keywords

Prebiotics; Probiotics; Gut microbiome; Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Change in Peripheral Blood Mononuclear Cells (pBMCs)

  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.

  Up to 24 weeks

• Change in Serum Neurofilament Light Concentration

  Change in serum neurofilament light concentration post-supplementation as compared to baseline. Serum neurofilament light (NfL) will be measured in terms of pg/ML.

  Up to 24 weeks

• Change in relative abundance of gut microbiome

  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.

  Up to 24 weeks

Secondary Outcomes (5)

• Modified Fatigue Impact Scale

  Up to 24 weeks

• Bowel Control Scale

  Up to 24 weeks

• Patient Determined Disease Steps

  Up to 24 weeks

• Multiple Sclerosis Rating Scale

  Up to 24 weeks

• Patient Health Questionnaire

  Up to 24 weeks

Study Arms (2)

Prebiotic/ Probiotic

OTHER

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).

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

Probiotic/ Prebiotic

OTHER

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).

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

Interventions

Prebiotics (Prebiotin Prebiotic Fiber Stick Pac) DIETARY_SUPPLEMENT

Commercially available Prebiotin Prebiotic. 2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)

Prebiotic/ Probiotic; Probiotic/ Prebiotic

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)

Prebiotic/ Probiotic; Probiotic/ Prebiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• National Multiple Sclerosis Society: collaborator
• Exegi Pharma: collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

University of Pittsburg

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Prebiotics; Probiotics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Rebecca Farber, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Zongqi Xia, MD

  University of Pittsburgh (Collaborator Site)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: July 31, 2019
• Study Start: March 11, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)