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.

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. - BIA study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54765

Enrollment

Registered

2018-09-07

Start date

2019-01-04

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

multiple sclerosis multiple sclerosis

Interventions

The interventions in this study consist of additional blood sampling, collection of stool samples, one additional MRI (including MRI contrast agent) and food intake registration for a limited period

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. The subject must give written informed consent 2. Males and females in the age of >= 18 and

Exclusion criteria

Exclusion criteria: 1. Has used probiotics within one month prior to start Cladribine

Design outcomes

Primary

Measure	Time frame
The main endpoint is the difference (in changes) in gut and oral microbiome at baseline and after 3 months of Cladribine treatment, between responders and non-responders.	—

Secondary

Measure	Time frame
The secondary objectives are to determine: 1. What is the difference between the gut and oral microbiome in patients who experience disease activity (relapse, radiological activity or disability progression) in comparison to patients without disease activity at baseline, 3, 12 and 24 months? 2. What is the difference between the immune profile in patients who experience disease activity in comparison to patients without disease activity at baseline, 3, 12 and 24 months? 3. Will cladribine treatment result in a more balanced microbial profile and a less inflammatory immune profile at 3, 12 and 24 months? 4. What is the difference between the immune profile, the gut and oral microbiome at baseline, 3, 12 and 24 months inbetween patients who experience disease activity (relapse, radiological activity or disability progression) at month 36 and month 48 and patients who do not experience disease activity?	—

Measure

Time frame

The secondary objectives are to determine: 1. What is the difference between the gut and oral microbiome in patients who experience disease activity (relapse, radiological activity or disability progression) in comparison to patients without disease activity at baseline, 3, 12 and 24 months? 2. What is the difference between the immune profile in patients who experience disease activity in comparison to patients without disease activity at baseline, 3, 12 and 24 months? 3. Will cladribine treatment result in a more balanced microbial profile and a less inflammatory immune profile at 3, 12 and 24 months? 4. What is the difference between the immune profile, the gut and oral microbiome at baseline, 3, 12 and 24 months inbetween patients who experience disease activity (relapse, radiological activity or disability progression) at month 36 and month 48 and patients who do not experience disease activity?

—

Countries

Belgium, Netherlands

Contacts

Public ContactS.A.M. Knippenberg

Zuyderland

s.knippenberg@zuyderland.nl0884594959

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026