Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT03183869
Eligibility Criteria:
Inclusion Criteria:
* Have a confirmed diagnosis of relapsing MS defined by the 2010 Revised McDonald Criteria for the Diagnosis of Multiple Sclerosis
* Any disease duration will be accepted.
* Have a baseline EDSS of = or \<7.0
* Older than 18 years of age.
* Be able to attend all clinic appointments without interruption
* Patients must be able to understand English sufficiently well to understand and comply with the clinic and medication schedules and procedures.
* Be willing and able to give written informed consent
* Negative blood pregnancy test at screening
Exclusion Criteria:
* Not meeting all of the above inclusion criteria
* Pregnancy or breastfeeding
* Current or recent \[in the last 90 days\] exposure to high dose corticosteroids
* Ongoing use of antibiotics
* Standard of care exclusions for MRI scans
* Presence of a chronic intestinal disease e.g. Celiac, malabsorption, colonic tumor
* Inability to provide informed written consent.
* Immunosuppression from transplantation, HIV, cancer chemotherapy or ongoing use of any immunosuppressive agents.
* Concomitant inflammatory diseases
* Pregnant women
* Any contra-indications for MRI. Participants are to be screened by a CMRTO (The College of Medical Radiation Technologists of Ontario) certified MRI Technologist in order to determine the MRI compatibility or exclusion of implantable/external devices according to the manufacturer's safety guidelines. The devises include cerebral aneurysm clips, neuro-stimulator, mechanical heart valves, cardiac stents, IUDs(intrauterine device), vena cava filters, shunts, embolization coils, cochlear implants, non-removable prosthesis/artificial limbs. Contraindications are pacemaker of defibrillator, shrapnel/metallic fragments, previous brain surgery, seizure, severe claustrophobia, weight or body index that will prevent a successful MRI study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03183869
Study Brief:
Protocol Section:
NCT03183869