Kallur Ranjith Kumar, Madapati Sreenadh, Mathur Ankita, Bhattacharya Sourish
Abode Biotec India Private Ltd., Hyderabad, India.
Process Design and Engineering Cell, CSIR-Central Salt and Marine Chemicals Research Institute, Bhavnagar, India.
Front Nutr. 2024 Feb 5;10:1310462. doi: 10.3389/fnut.2023.1310462. eCollection 2023.
Irritable bowel syndrome (IBS) is a common gastrointestinal condition. Some studies have shown the efficacy of probiotics in the treatment of irritable bowel syndrome (IBS). LMG S-31876 has been marketed as a dietary ingredient, but to date, its efficacy in diarrhea-predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated. Thus, a double-blind placebo-controlled multi-centered trial was planned to evaluate the safety and efficacy of LMG S-31876 in diarrhea-predominant IBS patients.
Study participants ( = 50) diagnosed with IBS prominent symptoms that include abdominal pain and other GI-related symptoms were treated with ProBC Plus (2 billion CFU) along with a placebo capsule once daily for approximately 8 weeks. Study participants were evaluated for the treatment success determined by the differences in stool consistency and frequency per day between the intervention and placebo groups over the study period.
The vital signs and the biochemistry parameters were under the normal range; the other parameters showed a significant result as compared to the placebo during the study period.
This study depicts a significant decline in the clinical symptoms such as abdominal pain, bloating, diarrhea, and frequency of the stool as compared to the placebo. All the parameters such as hematology, lipid profile, and vital signs were in the normal range during the supplementation of ProBC Plus for a period of 8 weeks. Furthermore, the study verified that LMG S-31876 and its probiotic product ProBC Plus at a dose of 2 billion/CFU/day has a prominent action in the relief from the clinical symptoms of IBS-D. Therefore, the product is intended safe to utilize for IBS-related symptoms.: The clinical study has been registered with CTRI/2023/01/048644 with https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77708&EncHid=24313.96864&userName=CTRI/2023/01/048644 [CTRI/2023/01/048644].
肠易激综合征（IBS）是一种常见的胃肠道疾病。一些研究表明益生菌对肠易激综合征（IBS）的治疗有效。LMG S - 31876已作为一种膳食成分上市，但迄今为止，其在腹泻型肠易激综合征（IBS）中的疗效尚未得到临床阐明。因此，计划开展一项双盲安慰剂对照多中心试验，以评估LMG S - 31876在腹泻型IBS患者中的安全性和疗效。
对50名被诊断为具有包括腹痛和其他胃肠道相关症状在内的IBS突出症状的研究参与者，每天一次用ProBC Plus（20亿CFU）加一粒安慰剂胶囊治疗约8周。通过比较干预组和安慰剂组在研究期间每天大便稠度和频率的差异来评估研究参与者的治疗成功率。
生命体征和生化参数在正常范围内；与安慰剂相比，研究期间其他参数显示出显著结果。
与安慰剂相比，本研究显示腹痛、腹胀、腹泻和大便频率等临床症状有显著下降。在补充ProBC Plus 8周期间，所有参数如血液学、血脂谱和生命体征均在正常范围内。此外，该研究证实LMG S - 31876及其益生菌产品ProBC Plus以20亿/CFU/天的剂量对缓解腹泻型IBS的临床症状有显著作用。因此，该产品用于IBS相关症状预计是安全的。该临床研究已在CTRI/2023/01/048644注册，网址为https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77708&EncHid=24313.96864&userName=CTRI/2023/01/048644 [CTRI/2023/01/048644] 。
