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Retrospective Study on the Role of SCFA Modulation in Multiple Sclerosis

NCT ID: NCT06746896

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-17

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Gut-brain axis SCFA Microbiota

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Healthy Controls

Absence of neurological symptoms or known diagnosis, absence of a known gastrointestinal pathology.

No interventions assigned to this group

Newly diagnosed MS patients

Absence of a known gastrointestinal pathology.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role collaborator

Prof. Massimo Filippi

OTHER

Sponsor Role lead

Responsible Party

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Prof. Massimo Filippi

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS San Raffaele

Milan, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 32160527 (View on PubMed)

Other Identifiers

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Brainess FISM

Identifier Type: -

Identifier Source: org_study_id