Bacillus coagulans (B. coagulans) has garnered attention because of its ability to withstand harsh conditions in the gut environment, such as acidic and gastric juices, and provide beneficial effects on immune function.
However, few studies have delved into the immune-modulating properties of B. coagulans, addressing the interplay between stress, immune responses, and their interventions.
A double-blind, randomised, placebo-controlled clinical trial funded by Indian biotech company Abode Biotec sought to analyse the safety and efficacy of its ProBC Plus product (Bacillus coagulans LMG S-31876) on immunomodulation and various health parameters, including stress levels and biochemical markers.
The study involved a total of 50 Asian individuals aged between 18 and 60, who were diagnosed with ailments related to immune system dysfunction and stress-related disorders.
The participants were divided into two groups — one group received B. coagulans LMG S-31876 (2bn CFU/capsule per day), and the other was given a placebo that contains starch in equivalent weight per capsule as that of the study product, for a period of eight weeks.
The effects on the immune system was evaluated using the participants’ Immune Status questionnaire (ISQ) and Perceived Stress Scale (PSS) scores.
Results showed that the intervention group obtained higher mean ISQ scores and narrower confidence intervals compared to the placebo group.
“Favourable changes in immune status were more evident in weeks 4 and 8. A progressive improvement over time underscores the efficacy of ProBC Plus in enhancing immune status.
“These findings, supported by a highly significant p-value (p < 0.0001), suggest that the supplement had a substantial and beneficial impact on the immune modulation of the participants throughout the study period,” the authors wrote.
At week 4, the study product showed a significant reduction in perceived stress levels compared to the placebo (p < 0.0001). By week 8, the intervention group exhibited a substantial decrease in PSS scores from baseline compared to the placebo.
According to the researchers, the reduction in perceived stress over a period of time signifies a promising result, as previous studies have reported that chronic stress can affect the gastrointestinal tract and weaken the nervous system.
“Therefore, the ability of ProBC Plus to mitigate stress may contribute positively to the overall well-being of an individual.”
Cardiovascular support potential
In this study, secondary outcomes include the differences in haematological parameters between the intervention and placebo groups.
B. coagulans LMG S-31876 supplementation did not have a significant impact on levels of alanine transaminase (ALT) compared to the placebo.
Although there was a slight reduction in aspartate aminotransferase (AST) levels, the effect was not substantial enough to achieve statistical significance within the duration of the trial.
Both ALT and AST are enzymes found in the liver that convert food into energy.
However, the intervention group had a notable reduction in levels of alkaline phosphatase (ALP), an enzyme that helps break down proteins in the body, compared to the placebo group during the study period.
“These findings indicate that despite similar baseline ALP levels between the two groups, ProBC Plus may help reduce ALP levels over time, supporting its potential as an effective intervention.”
In addition, the probiotic exhibited better results in maintaining lipid values (mean high-density lipoprotein, low-density lipoprotein, total cholesterol, very low-density lipoprotein, and triglycerides) within a normal range, suggesting its potential for cardiovascular support.
“The levels of immunoglobulins (antibodies), including IgA and IgG, showed a decline over the study period, while IgM indicated a slight increase. While the results were not statistically significant, it may be due to the diversity of the study population in terms of age, genetics, and overall health
“Furthermore, the participants’ vital signs remained within the normal range throughout the study and did not vary from baseline, which demonstrates that ProBC Plus is safe for consumption and did not alter any physiological processes,” the authors added.
Source: Frontiers in Nutrition
https://doi.org/10.3389/fnut.2024.1484499
“Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial”
Authors: Ranjith Kumar Kallur, et al
