Potential Role of Microbiome in Tuberculosis

Last updated: October 9, 2024
Sponsor: Khyber Medical University Peshawar
Overall Status: Completed

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT04985994
DIR/KMU-EB/PR/000858
10289/KPK/NRPU/R&D/HEC/2019
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with TB after detailed history collection, clinical examination andlaboratory 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 physicalexamination and with a negative sputum culture result.

Exclusion

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 diseasecondition.

  8. Multidrug resistance TB patients

Study Design

Total Participants: 450
Study Start date:
August 22, 2021
Estimated Completion Date:
August 31, 2024

Study 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.

Connect with a study center

  • DTO Peshawar

    Peshawar, KP 23061
    Pakistan

    Site Not Available

  • Khyber Medical University

    Peshawar, KP 25110
    Pakistan

    Site Not Available

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