RecruitingOBSERVATIONAL

Characterization of Phenotype and Genotype of Early Onset Enteropathies

This research study is trying to understand more about serious gut problems that affect children and often start very early in life. These conditions can sometimes be grouped under the term 'inflammatory bowel disease'. The researchers want to find out what causes these issues by looking at people's genes (our body's instruction manual) and other biological information. They will collect samples, mostly blood, from children with these conditions and also from their healthy family members. By studying these samples, they hope to learn how our bodies normally keep our guts healthy, especially given the many tiny bugs that live there. Understanding this better could lead to new ways to treat these conditions in the future.

At a glance

Status

Recruiting

Sponsor

Imagine Institute

Enrolment target

1,445

Start

16 Jun 2014

Estimated completion

15 Jun 2054

Inflammatory Bowel Disease

What is this study about?

This study is all about understanding why some children develop a serious gut condition very early in their lives. You might have heard of conditions like inflammatory bowel disease (IBD), which can cause inflammation and problems in the digestive system. When these problems start at a very young age, it can be particularly challenging.

The main goal of this research is to figure out the specific reasons behind these early-onset gut conditions. The scientists are particularly interested in two things: an individual's 'phenotype' and 'genotype'. Simply put, 'phenotype' refers to the noticeable characteristics or symptoms of the condition, like how severe it is or how it affects the body. 'Genotype' refers to the genetic makeup – the unique instructions in our DNA that can influence our health. By studying both, researchers hope to get a clearer picture of why these conditions develop.

To do this, the research team will collect biological samples, mainly blood, from children with these early gut conditions and also from their close relatives who are healthy. By comparing samples, they can look for differences in genes and other factors. This could help them identify the 'missing pieces' or 'faulty instructions' that might lead to these conditions. Ultimately, a deeper understanding of these genetic and biological pathways could pave the way for creating new and more effective treatments in the future, helping children live healthier lives.

Key takeaways

This study aims to understand serious gut conditions in children.
It focuses on genetics and other bodily factors.
Blood samples will be collected from affected children and healthy family members.
The goal is to find better ways to keep guts healthy in the future.
Participation is voluntary and primarily involves providing samples.

Who may be eligible?

This study is looking for children who have a severe, ongoing gut condition that started before their sixth birthday, and ideally, within their first two years of life. We are especially interested if there's a family history of similar gut problems, meaning other family members also have the condition, which could suggest a genetic link.

We are also welcoming family members of these children, even if the family member's gut condition started later in life. Their participation is important for comparison and to help understand any family patterns.

However, you cannot take part in this study if you have been involved in another clinical trial that tested a new medicine or treatment in the last 30 days. This is to make sure your results aren't affected by other ongoing treatments.

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.

Does your child have a serious, ongoing gut condition?
Did their symptoms start before their 6th birthday (or even earlier, before age 2)?
Is there a family history of similar gut problems?
Are you a relative of someone with one of these gut conditions?
Have you participated in any new treatment trials in the last 30 days? (If yes, you might not be eligible).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you or your child will be asked to provide some biological samples, mainly blood samples. These samples will be used for genetic testing and other analyses to understand the condition better. The research team will explain exactly what taking a sample involves, how much blood will be needed, and how often this might happen.

There are no specific medications or new treatments being given as part of this study. It's purely an observational study, meaning researchers are collecting information and samples to learn more. You won't have to follow any special diet or take any experimental drugs. The total duration of your participation will depend on the sample collection schedule, which will be discussed with you in detail by the study team.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of early-onset gut conditions, which could lead to improved treatments for future children. There is no direct medical benefit to you or your child from participating. The risks are generally low, mainly related to giving blood samples, such as minor bruising or discomfort at the injection site. All procedures will be carried out by trained professionals. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your or your child's medical care.

Locations (12)

Centre Hospitalier Pellegrin-Enfants
Verified postcode
Bordeaux, France· Recruiting
Hôpital pédiatrique de Lyon
Verified postcode
Bron, France· Recruiting
Hôpital Jeanne de Flandre, CHRU de Lille
Verified postcode
Lille, France· Recruiting
Hôpital d'enfants de la Timone
Verified postcode
Marseille, France· Recruiting
Hôpital Saint Antoine
Verified postcode
Paris, France· Recruiting
Necker - Enfants Malades Hospital
Verified postcode
Paris, France· Recruiting
Hôpital Robert Debré
Verified postcode
Paris, France· Recruiting
Hôpital Trousseau
Verified postcode
Paris, France· Recruiting
Hôpital Sud
Verified postcode
Rennes, France· Recruiting
CHU Hautepierre
Verified postcode
Strasbourg, France· Not yet recruiting
Hôpital des Enfants
Verified postcode
Toulouse, France· Recruiting
Hôpital Clocheville, CHU de Tours
Verified postcode
Tours, France· Recruiting

Common questions

What does 'early onset enteropathy' mean?

It's a medical term for a serious gut problem or bowel condition that starts very early, typically in childhood, often before the age of six.

Will my child receive new medicine in this study?

No, this study is about understanding the condition, not testing new medicines. You or your child will only be asked to provide samples like blood.

Why do you need samples from healthy relatives?

Comparing samples from healthy relatives helps researchers identify genetic differences or features that might be linked to the gut condition in affected family members.

What information will you get from my blood samples?

Researchers will look at your genes (DNA) and other biological markers in your blood to understand the causes and characteristics of the gut condition.

How long will I be involved in the study?

The study involves providing samples, mainly blood, during a visit or a few visits. The research team will tell you the exact schedule for sample collection.

How to find out more

Nadine Cerf-Bensussan

nadine.cerf-bensussan@inserm.fr + 33 1 42 75 42 88 Official trial record

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