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评估LMG S-31876的免疫调节作用和应激反应:一项双盲、安慰剂对照临床试验。

Evaluation of LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial.

作者信息

Kallur Ranjith Kumar, Madapati Sreenadh, Banerjee Mayuri, Mathur Ankita, Bhattacharya Sourish

机构信息

Abode Biotec India Pvt. Ltd., Hyderabad, Telangana, India.

Process Design and Engineering Cell, CSIR-Central Salt and Marine Chemicals Research Institute, Bhavnagar, Gujarat, India.

出版信息

Front Nutr. 2025 Jan 15;11:1484499. doi: 10.3389/fnut.2024.1484499. eCollection 2024.

Abstract

OBJECTIVE

The study aimed to analyze the safety and effectiveness of the ProBC Plus ( LMG S-31876) supplement across various health parameters, including stress levels, immunoglobulin levels, biochemical parameters, and vital signs.

METHODS

A randomized, double-blind, placebo-controlled clinical trial study was conducted involving 50 subjects diagnosed with ailments related to immune system dysfunction and stress related disorders. Patients were treated with ProBC Plus (2 billion colony-forming units [CFU]) along with a placebo capsule administered once daily for a period of 8 weeks.

RESULTS

The effects of ProBC Plus exhibited a positive response on stress relief, lipid parameters, immune status, and vital signs, which is further statistically significant ( value <0.05, 5% marginal error at 95% CI).

CONCLUSION

The study on ProBC Plus showed positive results. Over the course of 8 weeks, an improvement in the immune status was observed, as indicated by the immune status questionnaire. Enzymatic markers exhibited a significant decline in predicting a positive response toward treatment. In terms of lipid profile, ProBC Plus helps to maintain the value within the normal range, thereby predicting its potential as cardiovascular support. The vital signs remained within the normal range throughout the study. Therefore, ProBC Plus is considered safe for consumption and contributes to the overall well-being of individuals.

CLINICAL TRIAL REGISTRATION

https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77914&EncHid=24313.96864&userName=CTRI/2023/01/048720, CTRI/2023/01/048720.

摘要

目的

本研究旨在分析ProBC Plus(LMG S - 31876)补充剂在各种健康参数方面的安全性和有效性,这些参数包括压力水平、免疫球蛋白水平、生化参数和生命体征。

方法

进行了一项随机、双盲、安慰剂对照的临床试验研究,涉及50名被诊断患有与免疫系统功能障碍和压力相关疾病的受试者。患者接受ProBC Plus(20亿菌落形成单位[CFU])治疗,并每天服用一次安慰剂胶囊,为期8周。

结果

ProBC Plus的效果在缓解压力、脂质参数、免疫状态和生命体征方面呈现出积极反应,且具有统计学意义(P值<0.05,95%置信区间的边际误差为5%)。

结论

对ProBC Plus的研究显示出积极结果。在8周的过程中,免疫状态问卷显示免疫状态有所改善。酶标志物在预测治疗的积极反应方面显著下降。在脂质谱方面,ProBC Plus有助于将数值维持在正常范围内,从而预测其作为心血管支持的潜力。在整个研究过程中,生命体征保持在正常范围内。因此,ProBC Plus被认为食用安全,并有助于个人的整体健康。

临床试验注册

https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=77914&EncHid=24313.96864&userName=CTRI/2023/01/048720,CTRI/2023/01/048720。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4283/11774721/3b0431db939e/fnut-11-1484499-g001.jpg

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