NCT04038541Completed
Prebiotic vs Probiotic in Multiple Sclerosis
Prebiotic and Probiotic Treatment Trial in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 22 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 7 Jun 2019
- Start date
- 11 Mar 2020
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Columbia University
- Diseases
- Multiple sclerosis
- NCT number
- NCT04038541
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 11 Mar 2020 to the primary completion date, 30 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Steroid use within 4 weeks of enrollment
- 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
Other illness
- 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.
- 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
Other
- Active relapse within 3 months of enrollment
- Antibiotics use within 3 months of enrollment
- Daily pre or prebiotic use within 3 months of enrollment
- Active use of bismuth subsalicylate-containing products
- Currently pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pittsburg Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.