Skrzydło-Radomańska Barbara, Prozorow-Król Beata, Kurzeja-Mirosław Anetta, Cichoż-Lach Halina, Laskowska Katarzyna, Majsiak Emilia, Bierła Joanna B, Agnieszka Sowińska, Cukrowska Bożena
Department of Gastroenterology, Medical University of Lublin, Jaczewskiego 8, 20-950 Lublin, Poland.
Department of Health Promotion, Faculty Health of Sciences, Medical University of Lublin, Staszica 4/6, 20-081 Lublin, Poland.
J Clin Med. 2023 Jul 22;12(14):4838. doi: 10.3390/jcm12144838.
Probiotics offer a potential new therapeutic approach for irritable bowel syndrome (IBS), but current results are still controversial. The aim of this study was to assess the efficacy and safety of single-strain probiotic formulations in adult IBS patients and to compare the effects of NORDBIOTIC™ BI040 (DSM 33812/34614) and NORDBIOTIC™ BC300 (DSM 33836) in a prospective three-arm interventional randomized double-blind placebo-controlled clinical trial. The study included 123 IBS subjects diagnosed according to the Rome IV criteria. The primary outcomes were changes in symptom severity and symptom improvement as assessed using the IBS Severity Scoring System (IBS-SSS) after 4, 8, and 12 weeks of intervention and after 4 weeks of follow-up. Secondary outcomes included the assessment of individual IBS symptoms and the occurrence of adverse events. During the 12-week intervention, IBS-SSS scores significantly decreased (-values < 0.001) in the study groups but differences between the interventional and placebo groups did not reach statistical significance. However, at the 16th week of follow-up, a significant improvement in the total IBS-SSS score in comparison to the placebo group (20.5%) was found in 43.8% and 52.9% of the ( = 0.038, OR 3.0, [95% CI 1.1-8.6]) and the ( = 0.005, OR 4.6 [95% CI 1.5-12.2]) groups, respectively. had a beneficial effect on the intensity and frequency of pain, whereas decreased the bowel dissatisfaction. Both strains increased the percentage of patients with normal stool consistency, but only induced a decrease in the number of patients with constipation after 6 weeks of supplementation. Both probiotic strains were well tolerated, without differences in the occurrence of adverse events between groups. In conclusion, single-strain supplementation was safe and efficient in IBS patients but showed a different range of effects. BI040 primarily reduced the frequency and intensity of pain, while BC300 increased bowel satisfaction [ClinicalTrials.gov NCT05064930].
益生菌为肠易激综合征（IBS）提供了一种潜在的新治疗方法，但目前的结果仍存在争议。本研究的目的是评估单菌株益生菌制剂在成年IBS患者中的疗效和安全性，并在前瞻性三臂干预随机双盲安慰剂对照临床试验中比较NORDBIOTIC™ BI040（DSM 33812/34614）和NORDBIOTIC™ BC300（DSM 33836）的效果。该研究纳入了123名根据罗马IV标准诊断的IBS受试者。主要结局是在干预4、8和12周后以及随访4周后，使用IBS严重程度评分系统（IBS-SSS）评估的症状严重程度变化和症状改善情况。次要结局包括对个体IBS症状的评估和不良事件的发生情况。在12周的干预期间，研究组的IBS-SSS评分显著降低（P值<0.001），但干预组与安慰剂组之间的差异未达到统计学意义。然而，在随访第16周时，与安慰剂组相比，在BI040组（P = 0.038，OR 3.0，[95% CI 1.1 - 8.6]）和BC300组（P = 0.005，OR 4.6 [95% CI 1.5 - 12.2]）中分别有43.8%和52.9%的患者IBS-SSS总分有显著改善。BI040对疼痛强度和频率有有益影响，而BC300降低了肠道不适感。两种菌株均增加了大便性状正常患者的百分比，但仅BC300在补充6周后使便秘患者数量减少。两种益生菌菌株耐受性良好，各组间不良事件的发生率无差异。总之，单菌株补充对IBS患者是安全有效的，但显示出不同的效果范围。BI040主要降低疼痛频率和强度，而BC300提高肠道满意度[ClinicalTrials.gov NCT05064930] 。
