Ireland
--:--IST
Active, not recruiting Observational

Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

NCT06746896 · tracked via the Priya Life Science Italy tracker
Sponsor
Prof. Massimo Filippi
Phase
Observational
Started
2021-11-17
Last updated
2024-12-30

Condition(s) studied

Multiple Sclerosis

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: \- Volunteers that have preventively signed the informed consent to use their samples for additional studies. Exclusion Criteria: \- None

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Milan Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06746896 on ClinicalTrials.gov ↗ ← All trials in Italy