Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jun 24;20(1):379.
doi: 10.1186/s13063-019-3454-9.

The effects of probiotic Saccharomyces boulardii on the mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in patients with multiple sclerosis: study protocol for a double-blind randomized controlled clinical trial

Dawood Aghamohammadi  1 , Hormoz Ayromlou  2 , Neda Dolatkhah  3 , Fatemeh Jahanjoo  4 , Seyed Kazem Shakouri  4
Affiliations

The effects of probiotic Saccharomyces boulardii on the mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in patients with multiple sclerosis: study protocol for a double-blind randomized controlled clinical trial

Dawood Aghamohammadi et al. Trials. .

Abstract

Background: The relationship between gut dysbiosis and inflammatory diseases including multiple sclerosis (MS) is presently recognized as an important health issue. It has been established that some bacterial probiotic strains are effective in treating MS. This study will investigate the effect of yeast probiotic Saccharomyces boulardii (SB) supplements on mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in MS patients.

Methods/design: In this double-blind randomized controlled two-group parallel trial, 50 MS patients who meet the inclusion criteria will be recruited from outpatient settings. They will be randomly allocated to 4 months of daily placebo or the SB probiotic intervention. Blood samples will be taken from each participant at the baseline and after the intervention period to assess inflammation and oxidative stress. The primary endpoint will be the changes in their mental health evaluated by the 28-item General Health Questionnaire. The secondary endpoints include changes in: (1) quality of life, evaluated by the 36-item Short Form Questionnaire, (2) fatigue, evaluated by the Fatigue Severity Scale, (3) pain, evaluated by a visual analogue scale, and (4) serum levels of indices of inflammatory stress (high-sensitivity C-reactive protein) and oxidative stress (malondialdehyde and total antioxidant capacity). Moreover, any adverse events and side effects due to the intervention will be documented.

Discussion: There is a need to discover safe and practical methods for managing the symptoms of MS. This trial will gather evidence on the effects of a probiotic.

Trial registration: Iranian Clinical Trial Registry, IRCT20161022030424N1 . Registered on 9 April 2018.

Keywords: Inflammation; Multiple sclerosis; Oxidative stress; Probiotics; Saccharomyces boulardii.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Participant flow diagram
Fig. 2
Fig. 2
SPIRIT schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Amato Maria Pia, Derfuss Tobias, Hemmer Bernard, Liblau Roland, Montalban Xavier, Soelberg Sørensen Per, Miller David H, Alfredsson Lars, Aloisi Francesca, Amato Maria Pia, Ascherio Alberto, Baldin Elisa, Bjørnevik Kjetil, Comabella Manuel, Correale Jorge, Cortese Marianna, Derfuss Tobias, D’Hooghe Marie, Ghezzi Angelo, Gold Julian, Hellwig Kerstin, Hemmer Bernhard, Koch-Henricksen Nils, Langer Gould Annette, Liblau Roland, Linker Ralf, Lolli Francesco, Lucas Robyn, Lünemann Jan, Magyari Melinda, Massacesi Luca, Miller Ariel, Miller David H, Montalban Xavier, Monteyne Philippe, Mowry Ellen, Münz Christian, Nielsen Nete M, Olsson Tomas, Oreja-Guevara Celia, Otero Susana, Pugliatti Maura, Reingold Stephen, Riise Trond, Robertson Neil, Salvetti Marco, Sidhom Youssef, Smolders Joost, Soelberg Sørensen Per, Sollid Ludvig, Steiner Israel, Stenager Egon, Sundstrom Peter, Taylor Bruce V, Tremlett Helen, Trojano Maria, Uccelli Antonio, Waubant Emmanuelle, Wekerle Hartmut. Environmental modifiable risk factors for multiple sclerosis: Report from the 2016 ECTRIMS focused workshop. Multiple Sclerosis Journal. 2017;24(5):590–603. - PubMed
    1. Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, et al. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014;83(11):1022–1024. - PMC - PubMed
    1. Root MM, McGinn MC, Nieman DC, Henson DA, Heinz SA, Shanely RA, et al. Combined fruit and vegetable intake is correlated with improved inflammatory and oxidant status from a cross-sectional study in a community setting. Nutrients. 2012;4(1):29–41. - PMC - PubMed
    1. Dyer J, Davison G, Marcora SM, Mauger AR. Effect of a Mediterranean type diet on inflammatory and cartilage degradation biomarkers in patients with osteoarthritis. J Nutr Health Aging. 2017;21(5):562–566. - PMC - PubMed
    1. Frischer JM, Bramow S, Dal-Bianco A, Lucchinetti CF, Rauschka H, Schmidbauer M, et al. The relation between inflammation and neurodegeneration in multiple sclerosis brains. Brain. 2009;132(5):1175–1189. - PMC - PubMed

Publication types

MeSH terms

Substances