Influence of Gut Microbiome in Gallstone Disease
Researchers are investigating the connection between the bacteria in our gut (the gut microbiome) and gallstone disease. This study aims to understand if there's a link between these gut bacteria and serious gallstone complications like pancreatitis or acute cholecystitis. They also want to see how the gut microbiome changes after people have surgery to remove their gallbladder (cholecystectomy) and if these changes affect their recovery. Participants will be asked to provide stool samples at different times, including before and after surgery, and at follow-up appointments. This research hopes to provide a better understanding of gallstone disease and how the tiny organisms in our gut might influence it.
At a glance
What is this study about?
Gallstones are very common in the UK, affecting many people and sometimes leading to painful or serious health problems. More than 65,000 people have surgery to remove their gallbladder each year, which shows how big a problem this can be. There's growing evidence that the trillions of tiny bacteria and other organisms living in our gut, known as the gut microbiome, might play a part in gallstone disease. For example, studies have shown that people with gallstones might have a different mix of gut bacteria – sometimes fewer helpful ones and more potentially harmful ones – compared to those without. However, we don't yet fully understand how these gut bacteria specifically influence gallstone complications or what happens to them after surgery.
This study, called "Influence of Gut Microbiome in Gallstone Disease," aims to explore these important questions. Researchers want to better understand the makeup of gut bacteria in adult patients who have been diagnosed with gallstones. Specifically, they'll be looking to see if there's a link between certain gut bacteria and the development of complications from gallstones, such as severe pain (biliary colic), infections (cholangitis, cholecystitis), inflammation of the pancreas (pancreatitis), or blockages (gallstone ileus).
Additionally, the study will investigate how the gut microbiome changes after someone has their gallbladder removed through surgery (cholecystectomy). They'll also look at whether these changes affect a patient's recovery, both in the short term (like hospital stay or wound healing) and the longer term (such as developing diarrhoea after surgery). By collecting this information, the researchers hope to gain valuable insights that could one day lead to better ways to understand and manage gallstone disease.
Key takeaways
- This study investigates the link between gut bacteria and gallstone problems.
- It aims to understand if gut bacteria influence gallstone complications and recovery after surgery.
- Participants will provide stool samples over time and a food diary.
- Data from routine medical records will also be used.
- Taking part helps researchers learn more about gallstone disease for future patients.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
This study is looking for adults aged 18 and over who have recently been diagnosed with gallstones based on imaging tests (like an ultrasound or scan) at one of the East Kent University Hospitals NHS Foundation Trust hospitals. We welcome participants of all genders, ethnicities, and backgrounds, including pregnant women.
You can take part whether you're having traditional open surgery or keyhole (laparoscopic) surgery to remove your gallbladder. The most important thing is that you have a confirmed gallstone diagnosis and are an adult who can understand the study information and agree to take part.
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 18 years old or older?
- Have you recently been diagnosed with gallstones at an East Kent University Hospitals NHS Trust hospital?
- Do you understand what it means to take part in a research study?
- Are you able to provide stool samples as requested?
What does participation involve?
If you decide to take part in this study, you'll be asked to provide stool samples at several points in time. Initially, you'll provide a sample when you join the study. If you have surgery to remove your gallbladder, you'll be asked for another sample just before and then again after the surgery. Further samples will be requested at follow-up appointments, specifically at 6 months and 3 years after joining the study. If you experience any gallstone complications and attend the hospital, you might also be asked for an additional stool sample at that time. You can either provide these samples during a hospital visit or from the comfort of your own home, with pre-paid postage provided to send them back to the research team. Additionally, you will be asked to complete a simple 3-day food diary card. The researchers will also collect some of your routine medical information, like your medical history, blood test results, and imaging results, from your existing NHS records. The total duration of your participation could be up to 3 years.
Potential risks and benefits
Locations (1)
- EKHUFTVerified postcodeAshford, United Kingdom· Recruiting
Common questions
What are gallstones?
Gallstones are small, hard deposits that can form in the gallbladder, a small organ that stores bile. They can sometimes cause pain or other health problems.
What is a 'gut microbiome'?
The gut microbiome is the name for all the different types of bacteria and other tiny organisms that live in your digestive system. They play a role in many body functions, including digestion and immunity.
Why are you looking at gut bacteria and gallstones?
We believe there might be a link between the types of bacteria in your gut and whether you develop gallstone complications, or how you recover after gallbladder surgery. This study aims to explore that link.
Do I have to live near the hospital to take part?
You need to have been diagnosed with gallstones at an East Kent University Hospitals NHS Foundation Trust hospital. Stool samples for the study can be collected at home and mailed back.
Will taking part affect my medical care?
No, taking part in this study will not affect your standard medical care or treatment for your gallstones. It's a research study that runs alongside your usual care.
How to find out more
Charlotte Burford
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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