Pilot Study of Faecal Microbiota Transplantation in Multiple Sclerosis, a Phase-1 Study

Completed

• Conditions: 10007951; MS; Multiple Sclerosis

• Registration Number: NL-OMON48243
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Diagnosis of MS, currently not on medication for MS

Exclusion Criteria

MS-medication
Need for antibiotics
Swallowing disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: To assess the safety of FMT treatment in MS patients,<br /><br>measured by number of (serious) adverse events, clinical relapses, disease<br /><br>progression (EDSS), serum neurofilament levels, and MRI.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s): Systemic response to FMT measured by immunological<br /><br>parameters (e.g. lipidomics); microbiota dynamics assessed by faecal sampling.</p><br>