Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

NCT06746896 | Active Not Recruiting

• 1 other identifier: Brainess FISM
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Gut-brain axis; SCFA; Microbiota

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Gut microbial composition in MS patients versus healthy controls

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Prof. Massimo Filippi: lead
• Università Vita-Salute San Raffaele: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, Italy, 20132, Italy

Location

Related Publications (1)

• Duscha A, Gisevius B, Hirschberg S, Yissachar N, Stangl GI, Dawin E, Bader V, Haase S, Kaisler J, David C, Schneider R, Troisi R, Zent D, Hegelmaier T, Dokalis N, Gerstein S, Del Mare-Roumani S, Amidror S, Staszewski O, Poschmann G, Stuhler K, Hirche F, Balogh A, Kempa S, Trager P, Zaiss MM, Holm JB, Massa MG, Nielsen HB, Faissner A, Lukas C, Gatermann SG, Scholz M, Przuntek H, Prinz M, Forslund SK, Winklhofer KF, Muller DN, Linker RA, Gold R, Haghikia A. Propionic Acid Shapes the Multiple Sclerosis Disease Course by an Immunomodulatory Mechanism. Cell. 2020 Mar 19;180(6):1067-1080.e16. doi: 10.1016/j.cell.2020.02.035. Epub 2020 Mar 10.

  PMID: 32160527 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urines, plasma, CSF, stool.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: November 17, 2021
• Primary Completion: November 24, 2022
• Study Completion: September 30, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

IT (1)