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临床试验/NCT02541539
NCT02541539已完成不适用

Effects of Lactobacillus Casei in the Prevention of Upper Respiratory and Diarrheal Diseases Among Adults

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Serum immunoglobulin-A (IgA) level

研究概览

简要总结

This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ) in prevention of upper respiratory and gastrointestinal illnesses, which are found common among adults in Malaysia aged from 18 to 81 years.

详细描述

Probiotic can be defined as "live microorganisms that grant health effects to the host if consumed in sufficient amounts". Probiotic bacteria, which beneficially affect the host by improving the intestinal microbial balance, may affect the immune response, thus boosting the body system to combat against diseases.

Respiratory tract infections (RTI) can be described as infections on sinuses, throat, airways and lungs. Generally, RTI can be categorized into upper respiratory tract infections (URTI) and lower respiratory tract infections (LRTI). Some of the common URTI are like common cold, sinusitis, pharyngitis, epiglottitis and laryngotracheitis (croup) while examples of LRTI are bronchitis, bronchiolitis and pneumonia. URTI will be the main focus of this research. Despite continuous medical advancement, URTI remains a burden to the vast global communities.In Malaysia, URTI take out a proportion of 16.5% and 21.2% of the diseases diagnosed in public and private health clinics respectively.

Diarrhea is one of the most common symptoms for gastrointestinal diseases. Diarrhea is commonly defined as three or more loose or watery stools in the last 24 hours. Probiotics such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus have been reported to reduce diarrhea-related symptoms in a strain-dependent and dose-dependent manner. The rationale for using probiotics in infectious diarrhoea is that they act against enteric pathogens by competing for available nutrients and binding sites, making the gut contents acid, producing a variety of chemicals, and increasing specific and non-specific immune responses.

Lactobacillus casei Zhang (LCZ) has been identified as a unique probiotic strain that shows favorable probiotic characteristics like high acid and bile tolerance, ability to colonize gastrointestinal tract, in addition to antibacterial, antioxidative and immunomodulatory properties. LCZ was first isolated from koumiss collected in Xilin Guole, Inner Mongolia, China by a group of researchers from Inner Mongolia Agricultural University. Koumiss is a type of fermented horse milk drink which is commonly found in Inner Mongolia, China and has been reported to treat digestive diseases and chronic diseases.

LCZ is already commercially available and currently marketed in China since 2010, in the form of beverages, tablets, powders and capsules. Among the well known products present in the market are Bio-Plus, a type of plant based fermented soymilk beverages, Sci-Plus, and a multiple probiotic tablet. Research and development involving LCZ have won many awards. Among them are 2009 National Science and Technology Progress Award of China (second prize), 2009 Inner Mongolia Natural Science Award (first prize) and the sixth DBN Technology Achievement Award. In addition, up to September 2014, 11 patents were filed and approved while 8 more patents were in the review stage. Besides that, 82 research papers related to LCZ were also published.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male/ female subjects
  • 18-81 years old
  • Body mass index (BMI) within a healthy range
  • Willing to commit throughout the experiment

排除标准

  • Type-1 diabetes
  • Long term medication due to certain severe illness
  • Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Vegetarian

研究组 & 干预措施

Lactobacillus casei Zhang

Active Comparator

Intervention consists of daily administration of 2g probiotic Lactobacillus casei Zhang, administered daily at a fixed dosage of 9 log CFU/sachet/day and continue for 12 months.

干预措施: Lactobacillus casei Zhang (Dietary Supplement)

Placebo

Placebo Comparator

Intervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 months.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Serum immunoglobulin-A (IgA) level

时间窗: 12 months

IgA as an indicator for immunology, in assessing severity of upper respiratory illnesses between number of adult participants taking LCZ vs. placebo

Bristol stool chart scale

时间窗: 12 months

Bristol stool scale (from a scale of 1-7; scale of 1 representing hard lump, and 7 representing liquid with no solid pieces) as an indicator for assessing severity of gastrointestinal-related diarrheal illnesses between number of adult participants taking LCZ vs. placebo

次要结局

  • Fecal microbiota profiling(12 months)

研究者

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

Min-Tze LIONG

Associate Professor Dr

Universiti Sains Malaysia

研究点 (2)

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