NCT04985994Completed
Potential Role of Microbiome in Tuberculosis
Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 10 Oct 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 450 (actual)
- First submitted
- 22 Jul 2021
- Start date
- 22 Aug 2021
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Khyber Medical University Peshawar
- Diseases
- Tuberculosis
- NCT number
- NCT04985994
What you commit to
- Study type: Observational
- Participants enrolled: 450
- From 22 Aug 2021 to the primary completion date, 31 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Already on anti-TB treatment or previously treated for TB.
Other illness
- Having diarrhea or other major gastrointestinal disorders.
- Patients with liver or renal dysfunction, or having any other chronic disease condition.
Other
- Severely anemic (Hb \< 10g/dL).
- 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.
- Multidrug resistance TB patients
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Khyber Medical University Coordinator of this site? Confirm its status | Peshawar | Pakistan | Unknown status |
| DTO Peshawar Coordinator of this site? Confirm its status | Peshawar | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.