Potential Role of Microbiome in Tuberculosis (Micro-STOP)

Khyber Medical University Peshawar

Status: Completed

Conditions: Tuberculosis

Study type: Observational

Funder types: Other

Identifiers

NCT04985994

10289/KPK/NRPU/R&D/HEC/2019 (Other Grant/Funding Number)

DIR/KMU-EB/PR/000858

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Diagnosed with TB after detailed history collection, clinical examination and laboratory assessment (sputum culture positive).
2. Aged 18 - 65 years.
3. Willing to participate in the study.
4. Healthy controls are those who are free of TB symptoms, healthy on physical examination and with a negative sputum culture result.

Exclusion criteria

1. Already on anti-TB treatment or previously treated for TB.
2. Severely anemic (Hb < 10g/dL).
3. Having diarrhea or other major gastrointestinal disorders.
4. Using or have used aminoglycoside or quinolones antibiotics in the past one month.
5. Using a medically prescribed diet or nutrition supplement.
6. Pregnant or lactating women.
7. Patients with liver or renal dysfunction, or having any other chronic disease condition.
8. Multidrug resistance TB patients

Trial design

450 participants in 2 patient groups

Tuberculosis Patients

Description:

1. Diagnosed with pulmonary TB after detailed history collection, clinical examination, and laboratory assessment (sputum culture positive). 2. Aged 18 years or above. 3. Willing to participate in the study.

Healthy Volunteers

Description:

1. Healthy subjects with no symptoms or history of pulmonary TB 2. Negative sputum culture 3. Matched for sex and age (±5 years) with the TB patient group.