Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
NCT04930744
Actinomycetales Infections, Bacterial Infections
Johannesburg, Gauteng, South Africa
View Trial DetailsNCT Number: NCT04985994
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
DTO Peshawar, Peshawar, Khyber Pakhtunkhwa, Pakistan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 1 year
To determine gut microbiome diversity and functional potential at baseline and compare with healthy controls
Time frame: 1 year
To determine oral microbiome diversity and functional potential at baseline and compare with healthy controls
Time frame: 1 year
Time frame: Two years
To describe the occurrence of gut microbial dysbiosis and its association with adverse reaction and treatment failure in TB patients.
Time frame: 2 years
Khyber Medical University Peshawar
Other
Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study
Acronym: Micro-STOP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04930744
Actinomycetales Infections, Bacterial Infections
Johannesburg, Gauteng, South Africa
View Trial DetailsNCT05382312
Actinomycetales Infections, Bacterial Infections
Bellville, South Africa
View Trial DetailsNCT05007821
Actinomycetales Infections, Bacterial Infections
Gaborone, South-East District, Botswana
View Trial DetailsNCT04865536
Actinomycetales Infections, Bacterial Infections
Fair Lawn, New Jersey, United States
View Trial Details