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The purpose of this study is to demonstrate the superiority of propionic acid over placebo as add on treatment in multiple sclerosis (MS).
This is a single-center, double-blinded, randomized trial. One hundred multiple sclerosis (MS) patients will be randomly assigned in a 2:1 ratio to receive either 100 mg of propionic acid or a placebo over a period of 90 days. Outcome measures will encompass NfL and GFAP levels, fatigue scores, quality of life assessments, and physical examinations. Additionally, subgroup analysis will involve the evaluation of MRI and MEG data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propionic acid 1000 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propionic acid 1000 mg capsule | Dietary Supplement | Patients will be assigned to propionic acid or placebo as add on MS treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum neurofilament light chain (NfL) | assessed as pg/ml | 90 days |
| Serum glial fibrillary acid protein (GFAP) | assessed as pg/ml | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Scale for Motor and Cognitive Functions (FSMC) | Fatigue Score, Questionnaire | 90 days |
| Walking test, 10 meters distance | assessed as seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salzburger Landeskliniken | Salzburg | State of Salzburg | 5020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32160527 | Background | 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. | |
| 41780143 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D018450 | Disease Progression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C029658 | propionic acid |
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| Placebo | Dietary Supplement | Patients will be assigned to propionic acid or placebo as add on MS treatment. |
|
| 90 days |
| cerebral MRI | number of rim lesions; subgroup analysis | 90 days |
| 36-Item Short Form Health Survey (SF-36) | Quality of Life, Questionnaire | 90 days |
| Magnetoencephalography (MEG) | Assessing neuronal slowing proposed as a marker of cognitive impairment in MS; Subgroup analysis | 90 days |
| 9-hole peg test | assessed in seconds | 90 days |
| Derived |
| Lerda-Casaccia T, Mitterwallner JM, Hitzl W, Bohm B, Cadamuro J, Huber-Schonauer U, Weichsler M, Radlberger RF, Wipfler P, Moser T. Association of lifestyle and metabolic factors with clinical performance in multiple sclerosis: A cross-sectional study. Med Clin (Barc). 2026 Apr;166(4):107358. doi: 10.1016/j.medcli.2026.107358. Epub 2026 Mar 3. English, Spanish. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |