Potential Role of Microbiome in Tuberculosis
Micro-STOP
Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study
2 other identifiers
observational
450
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedStudy Start
First participant enrolled
August 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedOctober 10, 2024
October 1, 2024
2.6 years
July 22, 2021
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Baseline Gut microbiome
1 year
Baseline Oral microbiome
1 year
Gut microbiome and associated factors
1 year
Microbial dysbiosis
Two years
Microbial signatures
2 years
Study Arms (2)
Tuberculosis Patients
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
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.
Eligibility Criteria
The study will be conducted primarily in three district levels (Peshawar, Mardan and Swat) TB diagnostic and treatment centers of Khyber Pakhtunkhwa province of Pakistan. These centers have been selected based on the highest TB prevalence in the year 2020
You may qualify if:
- 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.
You may not qualify if:
- Already on anti-TB treatment or previously treated for TB.
- Severely anemic (Hb \< 10g/dL).
- Having diarrhea or other major gastrointestinal disorders.
- 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.
- Patients with liver or renal dysfunction, or having any other chronic disease condition.
- Multidrug resistance TB patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khyber Medical University Peshawarlead
- University of Readingcollaborator
- TB Control Program Khyber Pakhtunkhwacollaborator
Study Sites (2)
DTO Peshawar
Peshawar, Khyber Pakhtunkhwa, 23061, Pakistan
Khyber Medical University
Peshawar, Khyber Pakhtunkhwa, 25110, Pakistan
Related Publications (1)
Shahzad M, Andrews SC, Ul-Haq Z. Exploring the role of Microbiome in Susceptibility, Treatment Response and Outcome among Tuberculosis Patients from Pakistan: study protocol for a prospective cohort study (Micro-STOP). BMJ Open. 2022 Jun 7;12(6):e058463. doi: 10.1136/bmjopen-2021-058463.
PMID: 35672071DERIVED
Biospecimen
Stool, Whole Blood, Salivary rinse
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Shahzad
Khyber Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 22, 2021
First Posted
August 2, 2021
Study Start
August 22, 2021
Primary Completion
March 31, 2024
Study Completion
August 31, 2024
Last Updated
October 10, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within one year after the data is published
- Access Criteria
- The information request should be send directly to the principal investigator by email.
Access to the trial IPD can be requested by qualified researchers with research or academic interests in Tuberculosis or Microbiome research. The individual researchers will be required to send an email to the principal investigator describing the need and rationale for IPD. However, the access will be provided only after the proposal and statistical analysis plan is reviewed by the principal investigator and ORIC office of Khyber Medical University. The party requesting the access will also be required to sign Data Sharing agreement and or Material transfer agreement. Before sharing, the principal investigator will make sure that the samples and data are coded and all the personal information are removed.