Tuberculosis Clinical Trial
— Micro-STOPOfficial title:
Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study
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.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | August 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | DTO Peshawar | Peshawar | KP |
Pakistan | Khyber Medical University | Peshawar | KP |
Lead Sponsor | Collaborator |
---|---|
Khyber Medical University Peshawar | TB Control Program Khyber Pakhtunkhwa, University of Reading |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut microbiome diversity and functional potential | 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. | 2 Years | |
Secondary | Baseline Gut microbiome | To determine gut microbiome diversity and functional potential at baseline and compare with healthy controls | 1 year | |
Secondary | Baseline Oral microbiome | To determine oral microbiome diversity and functional potential at baseline and compare with healthy controls | 1 year | |
Secondary | Gut microbiome and associated factors | 3. To assess the relationship between gut microbiome and socio-demographic characteristics and dietary intake in TB patients at baseline, before the start of anti-tuberculosis treatment. | 1 year | |
Secondary | Microbial dysbiosis | To describe the occurrence of gut microbial dysbiosis and its association with adverse reaction and treatment failure in TB patients. | Two years | |
Secondary | Microbial signatures | 5. To identify specific oral and gut enterotypes associated with adverse reaction and unfavorable treatment outcomes. | 2 years |
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