TuberculosisMicro-STOPNCT04985994
Potential Role of Microbiome in Tuberculosis
An observational study of Tuberculosis, run by Khyber Medical University Peshawar at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 450 participants
- Where
- 2 sitesPakistan
- Study dates
- 22 Aug 2021to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
DTO Peshawar
Peshawar, Khyber Pakhtunkhwa, 23061
Khyber Medical University
Peshawar, Khyber Pakhtunkhwa, 25110
About this study
Official 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.
Read the detailed 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.
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Pulmonary TB, Microbiome, Immunity, Nutrition, Treatment response, Treatment Outcome, Gut microbiome, Oral Microbiome, Inflammation, Dietary intake
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Secondary outcomes (5)
Baseline Gut microbiome
To determine gut microbiome diversity and functional potential at baseline and compare with healthy controls
Measured: 1 year
Baseline Oral microbiome
To determine oral microbiome diversity and functional potential at baseline and compare with healthy controls
Measured: 1 year
Gut microbiome and associated factors
- 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.
Measured: 1 year
Microbial dysbiosis
To describe the occurrence of gut microbial dysbiosis and its association with adverse reaction and treatment failure in TB patients.
Measured: Two years
Microbial signatures
- To identify specific oral and gut enterotypes associated with adverse reaction and unfavorable treatment outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start22 Aug 2021
- Primary completion31 Mar 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, TB Control Program Khyber Pakhtunkhwa
- Responsible party
- Principal investigator, Muhammad Shahzad, Khyber Medical University Peshawar
- Investigators
- Muhammad Shahzad, Principal investigator, Khyber Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985994
- Sponsor's protocol ID
- DIR/KMU-EB/PR/000858
- Other IDs
- 10289/KPK/NRPU/R&D/HEC/2019
- Acronym
- Micro-STOP
- Status last verified
- Oct 2024
- First submitted
- 22 Jul 2021
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35672071
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Microbiome in Susceptibility, Treatment Response and Outcome Among Tuberculosis Patients; a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04985994
- Acronym / sponsor ID
- Micro-STOP / DIR/KMU-EB/PR/000858
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Pulmonary TB, Microbiome, Immunity, Nutrition, Treatment response, Treatment Outcome, Gut microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- University of Reading, TB Control Program Khyber Pakhtunkhwa
- Study start
- 22 Aug 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome diversity and functional potential
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.
5 secondary outcomes
Baseline Gut microbiome
Time frame: 1 year
Baseline Oral microbiome
Time frame: 1 year
Gut microbiome and associated factors
Time frame: 1 year
Microbial dysbiosis
Time frame: Two years
Microbial signatures
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 35672071Shahzad 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Shahzad principal investigator
Khyber Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Khyber Medical University Peshawar at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome diversity and functional potential (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.