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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48243

Enrollment

Registered

2020-01-23

Start date

2021-09-28

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple Sclerosis

Interventions

All patients will be treated twice with FMT, after pre-treatment with oral vancomycin and bowel lavage. A single donor will be used for all participants. Faecal suspension will be provided by de Ned

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of MS, currently not on medication for MS

Exclusion criteria

Exclusion criteria: MS-medication Need for antibiotics Swallowing disorders

Design outcomes

Primary

Measure	Time frame
Primary Objective: To assess the safety of FMT treatment in MS patients, measured by number of (serious) adverse events, clinical relapses, disease progression (EDSS), serum neurofilament levels, and MRI.	—

Secondary

Measure	Time frame
Secondary Objective(s): Systemic response to FMT measured by immunological parameters (e.g. lipidomics); microbiota dynamics assessed by faecal sampling.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)