Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

December 24, 2024 updated by: Prof. Massimo Filippi

A Retrospective Study on the Role of Short-chain Fatty Acids 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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

20 healthy controls and 20 newly diagnosed not yet treated MS patients. Both HC and MS were recruited inside IRCCS San Raffaele. Both categories are composed of 50% females and 50% males. The age range for both categories is comprised between 28 and 65 years.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Controls
Absence of neurological symptoms or known diagnosis, absence of a known gastrointestinal pathology.
Newly diagnosed MS patients
Absence of a known gastrointestinal pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Massimo Filippi

Collaborators

Università Vita-Salute San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Actual)

November 24, 2022

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brainess FISM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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