Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

A Retrospective Study on the Role of Short-chain Fatty Acids Modulation in Multiple Sclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06746896

Enrollment

Registered

2024-12-24

Start date

2021-11-17

Completion date

2025-09-30

Last updated

2024-12-30

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

Conditions

Multiple Sclerosis

Keywords

Gut-brain axis, SCFA, Microbiota

Brief summary

Recent studies show that gut microbiota strongly influences multiple sclerosis. These data suggest that the microbiota could have a direct effect on MS pathogenesis, although the mechanisms through which it modulates central nervous system (CNS) neuroinflammation and neurodegeneration are still poorly defined. The microbiota mediates its action principally through synthesizing specific metabolites that act as messengers in host functions, such as the modulation of the immune and nervous system, tissue repair, and stemness. The short-chain fatty acids (SCFAs- mainly acetate, propionate, and butyrate), produced by the fermentation of dietary fibers, are a class of microbial metabolites of primary importance for host physiology. Thus, the objective is to establish a mechanistic link between gut microbiota dysbiosis, reflected by a different level of SCFAs and SCFA-producing bacteria species, and neuroimmune alterations in MS. Preliminary data show a differential metabolomic profile in urine samples of MS patients compared to healthy controls. The authors now aim at deepening previous findings by analysing also the SCFAs concentration in the urines, plasma and CSF by GC-MS (their level turned out to be too low to be measured by NMR) and the microbiota composition by shotgun metagenomics analysis, to track changes in the abundance of SCFAs-producing bacteria species.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

\- Volunteers that have preventively signed the informed consent to use their samples for additional studies.

Exclusion criteria

\- None

Design outcomes

Primary

Measure	Time frame	Description
Modulation of SCFAs levels in MS patients versus healthy controls.	Baseline	Quantification of SCFAs (mainly acetate, butyrate and propionate) in different biofluids and samples: urines, plasma and CSF. It will be obtained by GC-MS.

Secondary

Measure	Time frame	Description
Gut microbial composition in MS patients versus healthy controls	Baseline	To perform taxonomical and functional analysis of the intestinal microbiota. We will examine bacteria DNA from stool samples by shotgun metagenomic analysis.

Countries

Italy

Outcome results