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:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT05920018
Eligibility Criteria:
Inclusion Criteria:
* Relapsing-remitting multiple sclerosis according to current McDonald Criteria, EDSS maximal 5.5, 18-60 years
* stable treatment with first-line DMT (IFNbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months
* absence of a clinical relapse for at least 3 months before inclusion
* Written informed consent
Exclusion Criteria:
* diagnosis of primary or secondary progressive MS or other active autoimmune disease
* intake/administration of the following disease modifying therapies:
1. at any time point: alemtuzumab, cladribine
2. during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod
3. during the last 12 months before inclusion: mitoxantron, ocrelizumab, ofatumumab, rituximab
* ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium, prebiotics, such as omega-3-fatty acids)
* significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions)
* accompanying systemic immunosuppressive treatment
* relevant dietary restriction (e.g. strictly vegan nutrition)
* women during pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05920018
Study Brief:
Protocol Section:
NCT05920018