RecruitingOBSERVATIONAL

Functional Digestive Disorders Observatory

This study is called the Functional Digestive Disorders Observatory. It focuses on common gut problems such as Irritable Bowel Syndrome (IBS), ongoing tummy pain, and constipation, which often don't have a clear cause. These conditions affect many people and are a big reason why people see a gut specialist. Researchers want to understand why these problems happen and how the body works when someone has them. They are collecting health information and samples like blood and urine from adult patients who are already receiving routine care. By studying these details, they hope to find better ways to diagnose these conditions, predict who might respond well to certain treatments, and ultimately help improve care for people with these difficult gut issues.

At a glance

Status

Recruiting

Sponsor

University Hospital, Rouen

Enrolment target

2,000

Start

09 Oct 2020

Estimated completion

09 Oct 2030

Irritable Bowel Syndrome Dyspepsia Functional Constipation Faecal Incontinence Abdominal Pain (AP)Vomiting Syndrome

What is this study about?

Imagine your digestive system is like a busy motorway, and sometimes traffic jams or unexpected slowdowns happen even when there are no obvious roadworks. This study, called the Functional Digestive Disorders Observatory, is trying to understand these kinds of 'invisible' problems that affect your gut. Conditions like Irritable Bowel Syndrome (IBS), ongoing indigestion (dyspepsia), and even tummy pain or vomiting that doctors can't easily explain are very common. In fact, about 1 in 5 people experience them, and they're a top reason for visiting a gut specialist. Even if tests don't show a clear disease, these symptoms can be very real and disruptive.

Researchers know that these conditions are complicated. They might involve how your gut muscles move, how sensitive your gut feels, or even how your gut and brain communicate. Sometimes, even after someone with a long-term gut disease like Inflammatory Bowel Disease (IBD) is feeling better, they still have these 'functional' symptoms. This suggests there might be links between different types of gut issues. The main goal of this study is to gather information from people like you who are already going through routine care for these gut problems. By looking closely at your symptoms, medical history, and even samples like blood or urine that are collected as part of your usual check-ups, the researchers hope to build a clearer picture.

The idea is to find clues that could help doctors diagnose these conditions more accurately or predict which treatments might work best for different people. This study is purely about observing and learning from your experiences and medical details, not about trying new medications or treatments. All the information and samples are gathered as part of your standard care, meaning you wouldn’t have any extra appointments or procedures just for the study.

Key takeaways

This study helps understand common gut problems like IBS.
It uses existing health information and samples from your routine care.
No extra tests, appointments, or medications are involved.
The goal is to find better ways to diagnose and treat these conditions.
You can stop participating at any time without affecting your doctors' care.
It's open to adults aged 18 and over with ongoing digestive issues.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over, who has been experiencing a functional digestive disorder (like IBS or ongoing tummy pain without a clear cause) for at least three months. You also need to be receiving regular medical care for your condition.

There are a few reasons why you wouldn't be able to join. For example, if you are currently in prison or under certain legal protections (like guardianship), you can't take part. Also, if you have difficulty reading, understanding questionnaires, or communicating due to vision, psychiatric, or thinking problems, you wouldn't be able to participate. This is to make sure everyone involved can fully understand and agree to what's happening.

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 had digestive problems like IBS or tummy pain for at least 3 months?
Are you currently receiving regular medical care for your digestive condition?
Can you read, understand, and answer questions about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't have any extra appointments or procedures. All the information collected will come from your normal medical records, tests, and any samples (like blood, urine, or stool) that are already taken as part of your standard care for your gut condition. You won't be given any new medications or treatments specifically for this study, and you won't need any additional follow-up visits. The study simply involves the research team looking at the data and samples that are already being collected during your routine medical care at the hospital or clinic. Your participation would continue for as long as you are receiving care at the centre and have provided consent.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of common digestive conditions, which could lead to improved diagnosis and treatment for people in the future. As this is an observational study using information and samples already collected during your routine care, there are no additional direct risks to you. You are free to withdraw your consent and stop participating at any time without it affecting your medical care.

Locations (1)

Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Verified postcode
Rouen, France· Recruiting

Common questions

What is a 'functional digestive disorder'?

These are gut problems like IBS or ongoing tummy pain where tests don't show a clear disease, but the symptoms are very real.

Do I need to do anything extra if I join this study?

No, you won't have extra appointments or tests. The researchers will use information from your regular medical care.

Will this study give me new medication?

No, this is an observational study, which means it only collects information. It doesn't involve giving new treatments or medications.

What kind of information will you collect?

Researchers will look at your symptoms, medical history, and samples like blood or urine that are already taken during your routine check-ups.

Can I change my mind after joining?

Yes, you can choose to stop participating at any time, and it won't affect your medical care.

How to find out more

Anne-Marie AL LEROI, Professor

anne-marie.leroi@chu-rouen.fr 33232888990 Official trial record

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