All studies
RecruitingPHASE4INTERVENTIONAL

Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease

This study, called CAMEO, is for children aged 6 to 17 who have recently been diagnosed with Crohn's disease. Crohn's disease causes inflammation in the gut, leading to tummy pain, diarrhoea, and other issues. Doctors use special medicines called anti-TNF treatments to reduce this inflammation. The study aims to find out why these medicines work really well for some children, leading to complete healing, but not for others. Researchers will look at blood and stool tests, as well as a child's genes and gut health, before, during, and after a year of anti-TNF treatment. This will help doctors understand how to give the best, most personal care to children with Crohn's.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Connecticut Children's Medical Center
Enrolment target
900
Start
10 Jun 2023
Estimated completion
01 Jul 2029

What is this study about?

Crohn's disease is a condition that causes inflammation – that's swelling and redness – inside your child's digestive system, usually in the small or large bowel. This can lead to tummy pains, diarrhoea, blood in their poo, losing weight, or not growing as quickly as other children. While we don't know the exact cause, it's thought to involve the immune system in the gut reacting unusually to the many bacteria that live there. Things like diet, having antibiotics early in life, or a family history of Crohn's might increase the risk.

Doctors often use a type of medicine called anti-TNF therapy to calm this inflammation. These medicines work by blocking a chemical in the body called TNF, which plays a big part in causing inflammation. They can be given by drip or injection. This study aims to understand why this treatment works really well for some children, helping their gut completely heal, but doesn't work as well for others. They believe that giving this treatment early and in the right amount, guided by blood tests, can make a big difference.

To find out more, the study will look at different things like blood and stool samples, as well as a child's genes and how their gut inflammation is controlled. These tests will be done before starting anti-TNF treatment and then again during and after one year. Doctors will also use a colonoscopy (looking inside the bowel) and a special type of MRI scan to see how much healing has happened. The main goal is to heal both the inner lining and the deeper wall of the gut. By learning why some children heal and others don't, doctors hope to give even better, more personalised care in the future.

Key takeaways

  • A study looking at Crohn's disease in children aged 6-17.
  • Aims to understand why anti-TNF medicine works better for some.
  • Involves blood, stool, genetic tests, colonoscopies, and MRIs.
  • Hopes to improve personalised care for children with Crohn's.
  • No extra risks beyond standard medical care for Crohn's.
  • Participation lasts about two years.

Who may be eligible?

This study is looking for children aged between 6 and 17 years old who are suspected of having Crohn's disease and are about to have tests to confirm the diagnosis (like a colonoscopy).

If tests show they do have Crohn's disease, and they start anti-TNF medicine within six months of diagnosis, they may be able to continue in the study. Before joining, any stool tests for common tummy bugs must be clear. Also, your child shouldn't have been on certain strong medicines recently, like some steroids or investigational drugs, that might affect the study results. They also can't take part if they are pregnant or have serious uncontrolled health problems like poorly managed diabetes, or if they've had major bowel surgery for Crohn's right at diagnosis.

It's important that your child and their parent or guardian agree to take part, and that you're able to come to follow-up appointments for at least a year after starting treatment. If your child struggles with claustrophobia or can't have an MRI scan for other reasons, they might 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. Is your child aged between 6 and 17?
  2. Is your child newly suspected of having Crohn's disease?
  3. Can your child have an MRI scan?
  4. Are you able to attend appointments for at least two years?
  5. Has your child not recently used certain strong medicines?
  6. Is your child not pregnant?
Answer every question to see your result.

What does participation involve?

If your child is eligible, they'll be part of the study for about two years. It starts with tests at diagnosis, then continues for at least a year after they begin anti-TNF treatment. During this time, your child will have regular blood and stool tests to check for inflammation. They will also have a colonoscopy and a special MRI scan (which uses magnets and radio waves to create detailed images of the body) before starting treatment and then again one year later. These imaging tests help doctors see how much healing is happening inside the gut. The study will also involve looking at your child's genes to understand how inflammation is controlled in their body. These appointments will happen at around 27 children's hospitals across North America.

Potential risks and benefits

Participating in this study will help doctors learn more about Crohn's disease and how to treat it better, potentially benefiting many children in the future. There are no extra risks beyond those usually associated with having Crohn's disease itself and the standard treatments your child would receive anyway. The anti-TNF medicine and diagnostic tests (like colonoscopies and MRIs) are part of standard care for Crohn's. You are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (26)

  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States· Recruiting
  • Cedars-Sinai
    Verified postcode
    Los Angeles, United States· Recruiting
  • Rady Children's Hospital - San Diego and University of California, San Diego
    Verified postcode
    San Diego, United States· Active not recruiting
  • UCSF Benioff Children's Hospitals
    Verified postcode
    San Francisco, United States· Recruiting
  • Connecticut Children's Medical Center
    Verified postcode
    Hartford, United States· Recruiting
  • Emory University
    Verified postcode
    Atlanta, United States· Recruiting
  • Riley Hospital for Children at Indiana University Health
    Verified postcode
    Indianapolis, United States· Recruiting
  • The Johns Hopkins Children's Medical Center
    Verified postcode
    Baltimore, United States· Recruiting
  • Boston Children's Hospital
    Verified postcode
    Boston, United States· Recruiting
  • University of Michigan
    Verified postcode
    Ann Arbor, United States· Recruiting
  • Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health
    Verified postcode
    Morristown, United States· Recruiting
  • Cohen Children's Medical Center of NY
    Verified postcode
    Lake Success, United States· Recruiting

Common questions

What is anti-TNF therapy?

It's a special medicine given by drip or injection that helps reduce inflammation in the body, which is important for treating Crohn's disease.

Will my child automatically receive anti-TNF if they join?

Your child will receive anti-TNF treatment if their doctor decides it's the right course of action for their Crohn's disease, as part of their usual care.

What does a 'healing intestine' mean?

It means the swelling and damage inside the bowel has gone down, both on the surface (the lining) and deeper inside (the wall of the intestine).

Are there any extra tests for the study?

The study involves regular blood and stool tests, plus two colonoscopies and two MRI scans, which are generally part of managing Crohn's disease.

How long will my child be in the study?

Your child will be in the study for about two years, covering their diagnosis and at least a year of treatment.

How to find out more

Dena E Hopkins, MPH, CCRP

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 "Clinical, Imaging, and Endoscopic Outcomes of Children Newly…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.