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Lung Innate Immunity and Microbiome After Tuberculosis Exposure

This study aims to understand how your body's natural first line of defence (your 'innate immune system') and the tiny living organisms in your lungs (your 'respiratory microbiome') respond soon after you've been exposed to tuberculosis (TB). TB is a serious disease, and many people carry the germ without getting sick. We want to find out why some people's bodies manage to fight off the TB germ, while others don't. By looking closely at lung samples and comparing them with blood, we hope to discover what makes the immune system strong against TB. This knowledge could help in creating new and more effective ways to prevent TB in the future.

At a glance

Status
Recruiting
Sponsor
University of Oxford
Enrolment target
50
Start
15 Aug 2024
Estimated completion
01 Oct 2028

What is this study about?

Tuberculosis (TB) is a disease that affects millions worldwide, and it's a leading cause of death from a single infection. Surprisingly, it's thought that about a quarter of all people carry the TB germ, but only some of them actually get sick. We still don't fully understand why some people get sick and others don't, especially when it comes to the very first response their body has to the germ.

This study focuses on two main areas: your 'innate immune system' and your 'respiratory microbiome'. Your innate immune system is like your body's first alert system, jumping into action immediately when it encounters a germ. The 'microbiome' refers to all the tiny bacteria and other organisms that naturally live in and on your body, including in your lungs. We know that these little helpers can influence your health and how your body fights off infections. We believe that how your early immune response works, and how it interacts with your lung microbiome, might be key to protecting you from TB.

To figure this out, we'll be looking at samples from people who have recently been around someone with active TB. By studying these samples, both from the lungs (using something called sputum) and from blood, we can see what changes happen in the body's defence system over time. This will help us build a clearer picture of what's happening in the crucial early stages of exposure to the TB germ, hopefully leading to new ways to prevent this disease.

Key takeaways

  • Learn how the body fights TB early on.
  • No new medications are given in this study.
  • Helps search for better TB prevention methods.
  • Requires recent close contact with someone with active TB.
  • Involves blood and lung samples (sputum).

Who may be eligible?

This study is looking for adults aged between 18 and 65 years old. You would need to live in or close to London or Oxford for the whole study period. You should also be happy for the research team to look at your NHS medical records, including any blood tests or X-rays.

Specifically, you can join if you've recently (within the last 12 weeks) been in close contact with someone who has active, infectious TB and has been screened for TB through NHS services. This screening usually involves a blood test (called an IGRA) and sometimes a chest X-ray.

There are also some reasons why you might not be able to join. For example, if you've already had TB or been treated for latent (sleeping) TB, or if you have certain health conditions like a serious autoimmune disease, a weakened immune system (including HIV), or uncontrolled asthma. If you're pregnant or breastfeeding, or if you've recently taken certain medications like steroids or antibiotics, you might also not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 65 years old?
  2. Do you live near London or Oxford?
  3. Have you recently been in close contact with someone with active TB (within the last 12 weeks)?
  4. Have you *not* had TB disease or treatment for latent TB before?
  5. Do you *not* have certain serious health conditions like uncontrolled asthma or a weakened immune system?
  6. Are you happy for doctors to look at your NHS records for the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for a certain period. This will include several visits to the clinic where you might have blood samples taken and provide sputum samples (mucus you cough up from your lungs). The researchers will monitor your health and how your body responds over time. There won't be any new medicines given during this study; it's purely about observing and understanding your body's natural response. The exact number of visits and the total duration will be clearly explained to you before you agree to join.

Potential risks and benefits

By taking part, you'll be contributing important information that could help us better understand TB and potentially develop new ways to prevent it in the future, which is a key benefit to society. As with any study, there could be some minor risks, such as discomfort from blood tests or collecting sputum samples. All procedures will be carried out by trained professionals. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Churchill Hospital
    Verified postcode
    Oxford, United Kingdom· Recruiting
  • Centre for Clinical Vaccinology and Tropical Medicine
    Verified postcode
    Oxford, United Kingdom· Recruiting
  • Grove Building, Royal Free NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is latent TB?

Latent TB means you have the TB germ in your body, but it's 'asleep' and not making you sick. You can't spread it to others.

What is the 'microbiome'?

The microbiome is the community of tiny living organisms, like bacteria, that naturally live in and on your body, including in your lungs.

Will I get any new medicine in this study?

No, this study does not involve giving any new medications. It's about observing your body's natural reactions.

What is a 'close contact' for TB?

A close contact means you've spent a significant amount of time with someone who has active, infectious TB, usually in the same household or workplace.

Will my regular doctors know I'm in the study?

Yes, if you agree, the study team will look at your NHS records to understand your health history, and your doctors would be informed as needed for your care.

How to find out more

Timothy Fredsgaard-Jones, MBBS

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Lung Innate Immunity and Microbiome After Tuberculosis Expos…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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