The randomised, double-blind, placebo-controlled, three-arm intervention trial conducted a comprehensive assessment of the effects of Bifidobacterium lactis Nordbiotic BI040 (DSM 33812/34614) and Bacillus coagulans Nordbiotic BC300 (DSM 33836).
Researchers found single-strain supplementation was safe and efficient in IBS patients but showed a different range of effects. Bifidobacterium lactis BI040 primarily reduced the frequency and intensity of pain, while Bacillus coagulans BC300 increased bowel satisfaction.
The team explains: "These results highlight the potential of Nordbiotic probiotic strains in providing relief to IBS patients. The study emphasises the importance of selecting the appropriate probiotics strains tailored to individual patient needs."
Research background
Irritable bowel syndrome (IBS) is one of the most commonly diagnosed functional gastrointestinal disorders and is characterized by recurrent abdominal pain and discomfort associated with changes in bowel frequency and/or stool consistency in the absence of an organic disease.
IBS is classified on the basis of the stool pattern as diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), mixed bowel habits (IBS-M), and un-classified (IBS-U).
IBS pathogenesis is multifactorial with a spectrum of abnormalities, including mucosal inflammation, increased intestinal permeability, altered gut motility, visceral hypersensitivity, small-bowel bacterial overgrowth (SIBO), compromised gut microbiome compromised gut microbiome, and impaired neuroendocrinal communications.
It is currently supposed that gut microbiota dysbiosis may be a potential trigger for IBS, inducing most of the pathological conditions. Thus, the modulation of dysbiotic intestinal microbiota by biologically active biotics including probiotics is a promising treatment approach in IBS.
A systematic review and meta-analysis published in 2020 showed that single-strain formulations, particularly those containing Bifidobacterium or Lactobacillus strains, may be more effective in IBS patients.
Other reports demonstrated high efficacy of a new-generation probiotic—the lactic acid producing Bacillus coagulans.
The main objective of the current study therefore was to compare the effects of two different probiotic strains in a prospective three-arm interventional RDBPC clinical trial.
The study
The complete study involved 106 participants consisted of patients attending gastroenterology outpatient clinics between September 2021 and July 2022. The sample included female and male patients aged 18–70 years who were diagnosed with IBS.
Patients received capsules with a probiotic formulation containing 5x109 Bifidobacterium lactis BI040 (DSM33812/DSM34614) or 2x109 Bacillus coagulans BC300 (DSM 33836) or placebo over a period of 12 weeks.
The study schedule included six visits: the screening visit to qualify patients to be enrolled; the baseline visit after up to 14 days following the screening visit, at which participants were randomized to the intervention groups; three follow-up visits after a 1-week run-in observation, held at weeks 4, 8, and 12 ± 3 days after starting the intervention; and the final follow-up visit after finishing the intervention at week 16.
The primary outcomes included an assessment of IBS severity with the use of the IBS-SSS score and any improvement of clinical symptoms.
Secondary outcomes included changes in stool consistency evaluated using the BSF scale, the number of bowel movements per day, the severity of pain and flatulence, faecal urgency, the feeling of incomplete stool evacuation, and the effect of intervention on the occurrence of adverse events.
The resulting data suggests that both the Bifidobacterium lactis BI040 and Bacillus coagulans BC300 strains beneficially affect clinical symptoms in IBS patients but in a different range. Both strains improved the total IBS-SSS score, but Bifidobacterium lactis BI040 significantly reduced the frequency and intensity of pain, whereas Bacillus coagulans BC300 mainly ameliorated satisfaction from the bowel.
Both strains beneficially affected the stool consistency, increasing the percentage of patients with normal stools as assessed with the BSF scale, but only Bifidobacterium lactis BI040 supplementation significantly decreased the number of patients with constipation in comparison with the placebo.
The authors conclude: "Both strains had a positive effect on stool consistency. The results show species/strain-specific effectiveness in IBS patients and underline the role of proper selection of probiotics for the best approach according to patients’ specific needs."
Source: Journal of Clinical Medicine
https://doi.org/10.3390/jcm12144838
The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome—A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial
Authors: Skrzydło-R; Prozorow-Król, B.; Kurzeja-Mirosław, A.; Cichoz˙ -Lach, H.; Laskowska, K.; Majsiak, E.; Bierła, J.B.; Agnieszka, S.; Cukrowska, B.