Active not recruitingOBSERVATIONAL

Intestinal Microbiota of Patients Hospitalized With Sars-CoV-2

Scientists are studying how COVID-19 might change the helpful bacteria and other tiny living things (microbes) that live in your gut. They believe that the SARS-CoV-2 virus, which causes COVID-19, could alter these gut microbes, potentially affecting how your gut works and allowing tiny parts of the gut to leak. This leakage might be connected to how much virus is in your gut and could influence how unwell you</b> get with COVID-19 and how the illness progresses. To explore this, researchers are collecting poo samples from patients who are in hospital with COVID-19. By carefully examining these samples, they hope to understand the link between the virus, your gut microbes, and the overall effects of COVID-19 on your health.

At a glance

Status

Active not recruiting

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

Start

11 Jan 2022

Estimated completion

01 Jun 2026

COVID-19

What is this study about?

When you get COVID-19, it's not just your lungs that can be affected. Your digestive system, including your gut, can also react to the virus. Inside your gut, there's a huge community of tiny living things, like bacteria, known as the 'gut microbiota'. These microbes are really important for your health, helping with digestion and even your immune system.

This study is trying to understand if having COVID-19 changes this community of gut microbes. Researchers believe that the SARS-CoV-2 virus might upset the balance of these microbes. This upset could potentially make your gut lining more 'leaky', which could allow things to pass through that shouldn't. They also want to see if these changes in your gut are related to how much of the virus is in your digestive system.

Ultimately, the goal is to find out if these gut changes play a part in how you experience COVID-19. For example, do people with certain gut microbe changes have more severe symptoms, or does their illness progress differently? By looking at poo samples from patients with COVID-19, the researchers hope to gain important insights into the connection between the virus, your gut health, and the overall course of the disease.

Key takeaways

This study explores how COVID-19 affects the gut's tiny living things (microbes).
It aims to link changes in gut microbes to how severe COVID-19 symptoms become.
Participation involves providing a single poo (fecal) sample.
It is for adults aged 18 and over, hospitalised with confirmed COVID-19 in Nimes, France.
Your medical treatment for COVID-19 will not be affected by taking part.
Your contribution helps scientists better understand COVID-19.

Who may be eligible?

To be able to join this study, you would need to be in hospital in Nimes, France, and have a confirmed COVID-19 infection, meaning a positive test for the SARS-CoV-2 virus. You would also need to understand the study and agree to take part by signing a consent form. Importantly, you'd need to be covered by a health insurance plan.

There are several reasons why someone might not be able to join. For example, if you're already taking part in another study that could change your gut microbes, or if you've had certain digestive problems or surgery on your digestive system in the past year. People who are pregnant, breastfeeding, or receiving nutrition through a tube would also not be able to participate. They also can't include anyone who might not be able to properly understand the information about the study or give their informed consent, such as those under a court order or guardianship.

This study is open to both men and women aged 18 and older, with no upper age limit.

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.

Are you currently hospitalised in Nimes, France?
Do you have a confirmed positive test for COVID-19?
Are you 18 years old or older?
Have you *not* had digestive surgery in the last year or a long-lasting gut problem?
Are you *not* pregnant or breastfeeding?
Are you *not* already in another study that might affect your gut microbes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you would be asked to do is provide a poo (fecal) sample. This sample would allow the researchers to study the tiny living things in your gut. There is no mention of taking new medication, extra hospital visits, or follow-up appointments specifically for this study. Your medical team would continue to manage your COVID-19 care as usual.

Potential risks and benefits

Taking part in this study involves very little direct risk to you, as it mainly requires providing a poo sample, which is a non-invasive procedure. There isn't an immediate personal health benefit from taking part, as it won't directly change your COVID-19 treatment. However, your contribution will be very valuable to medical science, helping researchers better understand COVID-19 and potentially improving care for future patients. Remember, you can always change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (1)

CHU de Nimes
Verified postcode
Nîmes, France

Common questions

What is the 'gut microbiota'?

It's the community of trillions of tiny living things, mainly bacteria, that live in your digestive system and help keep you healthy.

Why are researchers looking at poo samples?

Poo samples contain a lot of information about the tiny living things in your gut, allowing scientists to study them without needing to do an internal examination.

Will taking part change my COVID-19 treatment?

No, taking part in this study will not change the medical care you receive for your COVID-19. Your doctors will continue to treat you as usual.

Is this study looking at a new medicine?

No, this is an observational study, meaning it's about understanding how COVID-19 affects the body. It isn't testing any new treatments or medicines.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time without having to give a reason, and it won't affect your medical care.