跳至主要内容
临床试验/NCT06183801
NCT06183801已完成不适用

GLAC Metabolic Regulatory Probiotics, the Evaluation to Improve the Human Metabolic Syndrome, Intestinal Microflora and Short Chain Fatty Acid.

Glac Biotech Co., Ltd2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Changes in gut microbiota ratios

研究概览

简要总结

The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated fromseveral aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.

详细描述

In recent years, the issue of gut microbiota and probiotics has been becoming very popular, and more and more gastrointestinal health foods have been developed and commercialized. The impact of gut microbiota on human health has received increasing attention and expectations from the world. Probiotics are one of the most recognized and positive health materials for consumers. Lactobacillus/probiotics, the main raw materials of health foods most frequently purchased by domestic consumers in recent years, have always ranked the first. They have certain improvement effects in terms of gastrointestinal improvement, immune regulation, and blood lipid regulation. There are currently about 30 probiotic manufacturers in Taiwan. Since the regulations do not have any clinical functional requirements for probiotic products, most probiotic products only describe the characteristics, functions and animal experiments of probiotics. There is no actual clinical experimental data to verify the effect of probiotic products on human intestinal flora. The probiotics researched and developed by GLAC Biotechnology company have undergone rigorous in vitro and animal tests, and actively cooperate with domestic and foreign hospitals to conduct human clinical trials to verify the function of the strains.

With the progress of human culture and lifestyle, many diseases of modern civilization have emerged one after another. Most of these diseases are caused by changes of lifestyle or diet, leading to the human body's metabolic imbalances, such as high blood sugar, high cholesterol, hypertension, hyperuricemia, liver dysfunction, and obesity. Gut dysbiosis and diseases associated with aging usually have such phenomenon like increased pathogenic bacteria, decreased probiotics decrease and declined gut microbiota diversity. The gut dysbiosis contributes to the aging gut and aging-related diseases in at least three aspects including production of Lipopolysaccharides (LPS), reduced levels of short chain fatty acids (SCFAs), and inflamm-aging. The next generation sequencing (NGS) technology can provide high throughput, high sensitivity and reliable detection, and then the investigators can understand improving effects of the human gut microbiota. The Aging and Disease Prevention Research Center (ADPRC) of the Fooyin university has a complete and skilled next generation sequencing (NGS) platform and a gut microbiota database included 5000 clinical cases, and thus provide the best clinical verification platform for probiotic products. Based on the common probiotic/pathogenic markers, reported in most of studies, and 4 specific domestic markers found in our study, the investigators have defined the domestic gut aging index score (GAIS) to predict the aging of the gut. The GASI provides an excellent discrimination. In addition, gut microbiota normally affects inflammatory cytokines by generating SCFAs to modulate the immune system against pathogens. The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated from several aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • The subject are willing to provide physical examination reports within the past 1 year.
  • The subject are willing to sign informed consent form.

排除标准

  • Pregnant women or preparing for pregnancy.
  • The subject were taking antibiotics.
  • One of parents are not Han Chinese or aboriginal.

结局指标

主要结局

Changes in gut microbiota ratios

时间窗: Day0、Day30、Day60、Day90、Day120、Day180

Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora.

blood biochemical indicators

时间窗: Day0、Day30、Day60、Day90、Day120、Day180

Detecting the changes of concentration in blood biochemical indexes . 1. glucose AC (mg/dL) 2. Glutamic Oxaloacetic Transaminase,GOT (U/L) 3. Glutamic Pyruvic Transaminase,GPT (U/L) 4. Blood urea nitrogen,BUN (mg/dL) 5. Creatinine (mg/dL) 6. Triglyceride,TG (mg/dL) 7. total cholesterol (mg/dL) 8. High-density lipoprotein,HDL (mg/dL) 9. Low-density lipoprotein,LDL (mg/dL)

Changes in gut aging index score(GAIS)

时间窗: Day0、Day30、Day60、Day90、Day120、Day180

Calculating probiotic/pathogenic ratios

次要结局

  • Evaluating the score difference of Gastrointestinal(GI) symptoms questionnaire(Day0、Day30、Day60、Day90、Day120、Day180)
  • Short chain fatty acid analysis(Day0、Day30、Day60、Day90、Day120、Day180)
  • Changes in sleep quality(Day0、Day30、Day60、Day90、Day120、Day180)
  • Evaluating the score difference of Physical symptoms questionnaire(Day0、Day30、Day60、Day90、Day120、Day180)
  • Changes in stool form(Day0、Day30、Day60、Day90、Day120、Day180)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Hsieh-Hsun Ho

R & D director

Glac Biotech Co., Ltd

研究点 (2)

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