跳至主要内容
临床试验/NCT06561724
NCT06561724Unknown不适用

The Application of Potential Biotechnologies to Develop Novel Probiotics Functional Food Products With High Viability for Modulating the Gut Microbiome Among Healthy and Under Stress Subiects

National Research Centre, Egypt2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
2
主要终点
Fecal secretory immune globulin A (sIgA)

研究概览

简要总结

The study described herein seeks to assess the extent to which diet supplementation of young Egyptian children, one of the most vulnerable groups to the risk of diarrhea, with prebiotic fiber can improve their gut health.

详细描述

The gastrointestinal tract (GI) is an indispensable organ for any human. In addition to digesting and extracting nutrients from consumed foods, it also houses the largest community of human-associated microbes (called human gut microbiota), plays a role in immune system development and modulation, participates in water and electrolyte balancing, and excretes waste products. Because the human gut is constantly affected by external stimuli and foreign objects via food ingestion, it is not surprising that GI tract diseases, and especially diarrheal disease, are one of the most common causes of human illness. Diarrhea is especially prevalent at younger age, and indeed many young Egyptian children are vulnerable to develop such illness.

Healthy GI tract is the most densely populated human-associated microbial habitat and harbors a highly diverse microbial community. This gut microbiota functions as an essential organ in nutrition, immunity, and physiology of human hosts. Gut microbes are responsible for polysaccharide hydrolysis, vitamin production, immune system stimulation, and modulation of gut motility. While healthy gut microbiome provides protection of the human host against pathogen invasion, microbiota disbalance opens doors for the host to be colonized by intestinal pathogens including viruses, virulent bacteria, and parasites, which all can cause diarrhea. The burden of gut infections is high in Egypt, especially among young children. The vulnerability of these groups to gut infections has been linked previously to the level of hygiene and the integrity of intestinal barrier function, and can also be associated with the prevalence of pathogenic microbes in consumed foods such as poultry. The consumption of contaminated food and water, poor health knowledge, and ineffective infection control programs are contributing considerably to the persistence of enteric infections.

One of the approaches to reduce the prevalence of intestinal infections and resulting diarrhea is to improve overall gut health, by promoting the development of healthy gut microbiota and strengthening gut barrier function. Many dietary components can affect the composition and function of human gut microbiome. Among these, dietary fiber constitutes a variety of polysaccharides that are largely undigested and unabsorbed by humans (who lack enzymes required to break them), but are readily degraded by microbes in the large bowel. Fiber species that are selectively utilized by microbes and provide health benefits to the host are called prebiotics. These prebiotic fibers, such as inulin, selectively promote growth and expansion of beneficial members of our gut community, thus making it harder for pathogens to establish themselves in the gut. Fiber degradation by resident gut microbes also increases the levels of beneficial short chain fatty acids (SCFAs), which were shown to improve gut barrier function and reduce tissue inflammation.

研究设计

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

盲法说明

Randomized blind parallel three -arm randomized controlled trial (RCT). The RCT is double-blind, in which both the nutritionist and the volunteers are blinded to the actual biscuit allocated to the volunteer; i.e., neither the nutritionist in charge of distributing the biscuit nor the volunteer knows whether the volunteer has received prebiotic rich biscuit or placebo.

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria were children aged ≥3 and below 6 years and the ability of the child's mother to comply with the research protocol and to collect the biological materials at predetermined dates.

排除标准

  • gastrointestinal diseases
  • chronic diseases (such as type 1 diabetes)
  • intake of antibiotics within the previous 3 months.

结局指标

主要结局

Fecal secretory immune globulin A (sIgA)

时间窗: 2 months

Fecal secretory s-IGA was assayed by the Chrom ELISA kit (Bio Vender research Diagnostics, Cat # RIC6100, Germany) and the instruction of the manufacturer was followed. Aliquots (80-120 mg) of the thawed fecal samples collected above at baseline and at the termination of the trial were suspended in 10-fold exes (15 m) shitoog a phspaste burier protered and entrifuged at 3o0 omn for s min. Tipes were simultaneously run in the ELISA and the concentration of s-IgA was read at 405 mm in ELISA reader against a standard curve and the results were expressed as mg faecal S-IgA per 100 gram stool.

次要结局

  • 16s rRNA(3 months)
  • Fecal Short-chain fatty acids(3 months)

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (2)

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