A prospective, observational, multi-centre study investigating alterations of gut microbiome with its subsequent interaction on the brain-immune-intestine axis in patients with active relapsing remitting Multiple Sclerosis who start with oral treatment.
Phase 4
Completed
- Conditions
- multiple sclerosis10029305
- Registration Number
- NL-OMON54765
- Lead Sponsor
- Sint Elisabeth Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1. The subject must give written informed consent
2. Males and females in the age of >= 18 and <= 60 years
3. Planned start Cladribine treatment within 4 weeks from screening
4. The subject must be prepared to and considered able to follow the protocol
during the whole trial period
Exclusion Criteria
1. Has used probiotics within one month prior to start Cladribine
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint is the difference (in changes) in gut and oral microbiome at<br /><br>baseline and after 3 months of Cladribine treatment, between responders and<br /><br>non-responders.</p><br>
- Secondary Outcome Measures
Name Time Method