Prebiotic vs Probiotic in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MS  

Official title:

Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038541
• Other study ID #: AAAR9614
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome (CIS)
• Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)
Commercially available Prebiotin Prebiotic. 2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)
• 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)

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	University of Pittsburg	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Exegi Pharma, National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Modified Fatigue Impact Scale	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.	Up to 24 weeks
Secondary	Bowel Control Scale	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.	Up to 24 weeks
Secondary	Patient Determined Disease Steps	Patient Determined Disease Steps assesses disability and walking ability in MS patients. Scores range from 0 (normal) to 8 (bedridden).	Up to 24 weeks
Secondary	Multiple Sclerosis Rating Scale	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).	Up to 24 weeks
Secondary	Patient Health Questionnaire	Patient Health Questionnaire helps identify symptoms that could be related to depression. The total score ranges from 0 (None) to 27 (Severe).	Up to 24 weeks