Probiotic eased pain and fatigue in RRMS, trial data show
BioDigest also improved patients' mental health and quality of life, researchers say
A commercial probiotic supplement containing the yeast Saccharomyces boulardii significantly eased pain and fatigue, and improved mental health and quality of life, in people with relapsing-remitting multiple sclerosis (RRMS), according to data from a clinical trial in Iran.
The probiotic, BioDigest, also reduced inflammation and oxidative stress, a form of cellular damage implicated in multiple sclerosis (MS), compared with a placebo.
The data “highlights the potential of probiotics as a non-pharmacological approach to improve the quality of life for individuals with MS by targeting multiple factors contributing to the disease’s progression and symptoms,” the researchers wrote.
The study, “The effect of probiotic supplementation on the clinical and para-clinical findings of multiple sclerosis: a randomized clinical trial,” was published in the journal Scientific Reports.
Recent research has suggested that alterations in the gut microbiome — the collection of bacteria, fungi, and viruses that live in the human digestive tract — may be linked to autoimmune diseases like MS.
In line with this, probiotics — or supplements containing specific live microorganisms — that regulate the gut microbiome composition have been shown in clinical trials to ease immune and inflammatory responses, reduce oxidative damage, and improve mental health.
“These findings indicate that probiotic supplementation could benefit various aspects of MS, including disability, mental health, inflammation, and metabolic conditions, by adjusting the gut microbiota,” the researchers wrote.
The benefits of probiotic in the gut microbiome
The yeast S. boulardii has been proven clinically effective in some gastrointestinal conditions, suggesting it may improve the composition of the gut microbiome. Yet, no studies to date have examined its effects in people with MS.
To learn more, researchers in Iran conducted a Phase 1 clinical trial (IRCT20161022030424N1) involving 40 people with RRMS. They were assigned randomly to receive either the BioDigest probiotic — whose capsules contain 250 mg of S. boulardii — or a placebo taken daily after lunch for more than four months.
In both groups, about two-thirds of participants were women, with a mean age in the mid-30s. All participants continued with their standard MS treatments and were encouraged to take vitamin D3 supplements. They also were instructed to record their dietary intake regularly.
The trial’s primary goal was to assess changes in mental health, using the General Health Questionnaire (GHQ-28), which addresses physical symptoms, anxiety, sleep, social dysfunction, and depression symptoms. Secondary measures included changes in fatigue, pain, quality of life, and a number of biomarkers of inflammation and oxidative damage.
Before treatment, there were no significant differences in GHQ-28. However, the probiotic group experienced a significantly greater improvement in scores related to physical symptoms and social dysfunction after four months, compared with the placebo group.
BioDigest group’s improvements significantly greater
While both groups experienced decreases in fatigue and pain over the four months, these improvements also were significantly greater in the BioDigest group.
Quality of life was assessed with the 36-item short form (SF-36) questionnaire. The probiotic supplement led to better quality of life scores in six of the eight SF-36 domains — namely physical and social functioning, vitality, pain, and physical health — compared with the placebo.
In most of these domains’ cases, scores improved with the probiotic, indicating better life quality, but decreased in the placebo group.
Finally, an analysis of blood samples collected before and after the intervention showed that supplementation with S. boulardii significantly decreased inflammation and increased the antioxidant capacity, compared to the placebo. However, a biomarker of oxidative stress was reduced equally in both groups.
The probiotic supplementation was well tolerated, and most patients complied with their treatment recommendations. The most common adverse events included constipation, weight gain, nausea, and increased fatigue, but no serious side effects were reported.
“The findings of this study suggest that [S. boulardii] may be a valuable adjunct therapy for controlling clinical symptoms, inflammation, and oxidative stress in MS patients,” the researchers wrote.
The mechanisms through which the yeast affects MS outcomes is still not understood, but researchers believe the probiotic may create a chain of events that starts with alterations in the gut microbiome. This leads to decreased inflammation and oxidative stress, which might influence the overall well-being of MS patients.
“Further research is needed to fully understand the probiotic’s mechanisms of action and determine its long-term effects,” they concluded.
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