Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06746896

Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, Italy, 20132

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Modulation of SCFAs levels in MS patients versus healthy controls.

    Time frame: 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 outcomes

  1. Gut microbial composition in MS patients versus healthy controls

    Time frame: Baseline

    To perform taxonomical and functional analysis of the intestinal microbiota. We will examine bacteria DNA from stool samples by shotgun metagenomic analysis.

Sponsors and collaborators

Lead sponsor

Prof. Massimo Filippi

Other

Collaborators

  • Università Vita-Salute San Raffaele

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.