Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Tuberculosis
- 发起方
- Khyber Medical University Peshawar
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Gut microbiome diversity and functional potential
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a deadly infectious disease and major global public health problem. Recent evidence from animal studies suggests that the microbiome plays a role in TB pathogenesis and immune response. However, until now, no similar study has been performed in humans and thus any influence of the microbiota on TB or vice versa remains unknown.
详细描述
Tuberculosis is among one of the most difficult to treat infections that require multidrug therapy for prolonged periods, in most cases 6-9 months. Treatment failure is still common and frequently observed (even where adherence to antibiotic therapy is maintained) in 15% of drug-susceptible infections and 31% for drug-resistant cases. Although poor patient compliance and the emergence of drug-resistant Mtb strains are generally implicated as a major cause of TB treatment failure, other factors such as the role of the microbiome in TB pathogenesis and reactivation are poorly considered. The human microbiome is a consortium/collection of all microorganisms (bacteria, archaea, viruses, and fungi) colonizing different habitats in the human body such as skin, gut, and mucosal surfaces and living in a commensal relationship with each other. Emerging evidence suggests a crucial role of the microbiome in hosts physiology, nutritional status, and development of the functional immune system. Microbial dysbiosis is the change in microbial composition or functional potential that has been implicated both in infectious diseases status as well as the development of non-communicable disease in hosts ranging from immune mediated diseases to intergenerational obesity and even cancers. Microbial dysbiosis at different body sites has also been reported in TB-associated comorbidities such as diabetes mellitus and malnutrition. However, to date, the role of the microbiome and microbial dysbiosis is not clear in the context of TB infections in humans. Therefore, this study aims to dissect the relationship between the microbiomes and its interaction with the immune system during TB infection, and anti-tuberculosis therapy in humans.
研究者
Muhammad Shahzad
Associate Professor
Khyber Medical University Peshawar
入排标准
入选标准
- •Diagnosed with TB after detailed history collection, clinical examination and laboratory assessment (sputum culture positive).
- •Aged 18 - 65 years.
- •Willing to participate in the study.
- •Healthy controls are those who are free of TB symptoms, healthy on physical examination and with a negative sputum culture result.
排除标准
- •Already on anti-TB treatment or previously treated for TB.
- •Severely anemic (Hb \< 10g/dL).
- •Having diarrhea or other major gastrointestinal disorders.
- •Using or have used aminoglycoside or quinolones antibiotics in the past one month.
- •Using a medically prescribed diet or nutrition supplement.
- •Pregnant or lactating women.
- •Patients with liver or renal dysfunction, or having any other chronic disease condition.
- •Multidrug resistance TB patients
结局指标
主要结局
Gut microbiome diversity and functional potential
时间窗: 2 Years
To explore the effect of TB infection and anti-tuberculosis therapy on gut microbiome diversity, functional potential and immune response in newly diagnosed TB patients from Pakistan.
次要结局
- Baseline Gut microbiome(1 year)
- Baseline Oral microbiome(1 year)
- Gut microbiome and associated factors(1 year)
- Microbial dysbiosis(Two years)
- Microbial signatures(2 years)